Viewing Study NCT01559259

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Ignite Creation Date: 2025-12-24 @ 2:42 PM
Ignite Modification Date: 2025-12-29 @ 8:10 PM
Study NCT ID: NCT01559259
Status: COMPLETED
Last Update Posted: 2020-05-19
First Post: 2012-03-19
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.', 'otherNumAtRisk': 30, 'otherNumAffected': 15, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.', 'otherNumAtRisk': 90, 'otherNumAffected': 33, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.', 'otherNumAtRisk': 93, 'otherNumAffected': 27, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.', 'otherNumAtRisk': 89, 'otherNumAffected': 22, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.', 'otherNumAtRisk': 92, 'otherNumAffected': 30, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Alveolar osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '29.6', 'spread': '15.6', 'groupId': 'OG002'}, {'value': '31.7', 'spread': '14.6', 'groupId': 'OG003'}, {'value': '28.8', 'spread': '15.3', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.28', 'ciLowerLimit': '20.33', 'ciUpperLimit': '32.22', 'groupDescription': 'Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.37', 'ciLowerLimit': '18.44', 'ciUpperLimit': '30.29', 'groupDescription': 'Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.48', 'ciLowerLimit': '21.53', 'ciUpperLimit': '33.42', 'groupDescription': 'Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.85', 'ciLowerLimit': '18.93', 'ciUpperLimit': '30.78', 'groupDescription': 'Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.501', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '-2.73', 'ciUpperLimit': '5.58', 'groupDescription': 'Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.817', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-4.61', 'ciUpperLimit': '3.64', 'groupDescription': 'Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.216', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.62', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '6.78', 'groupDescription': 'Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'From 0 hour up to 8 hours post-dose', 'description': 'SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[none\\] to 3 \\[severe\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Meaningful Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not analysed as median time to meaningful relief was greater than (\\>) 720 minutes/12 hours) for placebo group and therefore 95% CI was not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '44.5', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': '55.0'}, {'value': '54.1', 'groupId': 'OG002', 'lowerLimit': '44.7', 'upperLimit': '73.6'}, {'value': '45.9', 'groupId': 'OG003', 'lowerLimit': '42.2', 'upperLimit': '57.2'}, {'value': '56.2', 'groupId': 'OG004', 'lowerLimit': '52.0', 'upperLimit': '77.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.69', 'ciLowerLimit': '5.52', 'ciUpperLimit': '29.19', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.02', 'ciLowerLimit': '4.36', 'ciUpperLimit': '23.02', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.66', 'ciLowerLimit': '5.07', 'ciUpperLimit': '26.83', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.60', 'ciLowerLimit': '3.74', 'ciUpperLimit': '19.77', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.02', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.332', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.59', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.056', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.85', 'groupDescription': 'Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From 0 hour up to 12 hours post-dose', 'description': 'Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Confirmed First Perceptible Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not analysed as median time to confirmed first perceptible relief was \\>720 minutes (\\>12 hours) for placebo group and therefore 95% CI was not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '23.0'}, {'value': '22.8', 'groupId': 'OG002', 'lowerLimit': '19.9', 'upperLimit': '27.4'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '15.7', 'upperLimit': '21.8'}, {'value': '24.9', 'groupId': 'OG004', 'lowerLimit': '21.6', 'upperLimit': '28.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.10', 'ciLowerLimit': '5.24', 'ciUpperLimit': '27.91', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.88', 'ciLowerLimit': '3.86', 'ciUpperLimit': '20.44', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.47', 'ciLowerLimit': '4.98', 'ciUpperLimit': '26.42', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.11', 'ciLowerLimit': '3.52', 'ciUpperLimit': '18.68', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.04', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.570', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.49', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.93', 'groupDescription': 'HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From 0 hour up to 12 hours post-dose', 'description': "Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation).", 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Pain Relief Rating Score (PRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0.25 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG004'}]}]}, {'title': '0.5 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '1.2', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '1.1', 'groupId': 'OG004'}]}]}, {'title': '1.5 hour', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '2.5', 'spread': '1.2', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG004'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '1.2', 'groupId': 'OG003'}, {'value': '2.7', 'spread': '1.3', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '1.2', 'groupId': 'OG003'}, {'value': '2.7', 'spread': '1.4', 'groupId': 'OG004'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '1.4', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '7 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '9 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '10 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '11 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '1.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.71', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.64', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.79', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.155', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.54', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.135', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.39', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.350', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.32', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.024', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.47', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.77', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.70', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.78', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.30', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.77', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.70', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.79', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.12', 'ciLowerLimit': '1.66', 'ciUpperLimit': '2.58', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1.50', 'ciUpperLimit': '2.42', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.14', 'ciLowerLimit': '1.67', 'ciUpperLimit': '2.60', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.20', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.70', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.181', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.54', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.016', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.72', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.98', 'ciUpperLimit': '2.88', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '1.72', 'ciUpperLimit': '2.62', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.46', 'ciLowerLimit': '2.01', 'ciUpperLimit': '2.91', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '1.68', 'ciUpperLimit': '2.58', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.065', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.61', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.817', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.35', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.043', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.64', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.53', 'ciLowerLimit': '2.06', 'ciUpperLimit': '3.01', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '1.87', 'ciUpperLimit': '2.82', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '2.15', 'ciUpperLimit': '3.11', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '1.89', 'ciUpperLimit': '2.84', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.312', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.51', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.910', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.31', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.113', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.60', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.48', 'ciLowerLimit': '1.98', 'ciUpperLimit': '2.97', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.25', 'ciLowerLimit': '1.76', 'ciUpperLimit': '2.75', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '2.02', 'ciUpperLimit': '3.01', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.35', 'ciLowerLimit': '1.86', 'ciUpperLimit': '2.85', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.482', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.47', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.573', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.24', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.368', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.50', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '1.88', 'ciUpperLimit': '2.91', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '1.66', 'ciUpperLimit': '2.68', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '1.93', 'ciUpperLimit': '2.96', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.23', 'ciLowerLimit': '1.72', 'ciUpperLimit': '2.74', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.352', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.53', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.771', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.30', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.235', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.58', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.32', 'ciLowerLimit': '1.79', 'ciUpperLimit': '2.86', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.52', 'ciUpperLimit': '2.58', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.37', 'ciLowerLimit': '1.83', 'ciUpperLimit': '2.90', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.20', 'ciLowerLimit': '1.66', 'ciUpperLimit': '2.73', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.510', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.50', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.442', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.23', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.372', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.54', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.55', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '1.25', 'ciUpperLimit': '2.40', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.57', 'ciUpperLimit': '2.72', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '1.30', 'ciUpperLimit': '2.45', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.639', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.50', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.803', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.35', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.184', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.67', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.07', 'ciUpperLimit': '2.26', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '0.99', 'ciUpperLimit': '2.17', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '1.25', 'ciUpperLimit': '2.43', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.28', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.910', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.39', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.607', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.30', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.484', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.56', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.86', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.97', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.99', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.89', 'ciUpperLimit': '2.10', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.256', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.18', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.526', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.29', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.602', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.31', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.56', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.59', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.86', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.82', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.224', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.16', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.283', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.19', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.860', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.46', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.03', 'ciUpperLimit': '1.22', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.24', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.62', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.54', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.129', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.09', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.154', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.11', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.714', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.49', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.96', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.136', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '1.03', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.19', 'ciUpperLimit': '1.37', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.41', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.04', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.070', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.03', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.822', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.37', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.327', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.83', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.224', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.89', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.19', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.15', 'ciUpperLimit': '1.25', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '-0.04', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.064', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.02', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.721', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.32', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'Participants answered a question: "how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Difference on 4-Point Categorical Scale (PID4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0.25 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': '0.5 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': '1.5 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '7 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '1.1', 'groupId': 'OG004'}]}]}, {'title': '9 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '10 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '11 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.42', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.224', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.33', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.44', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.501', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.27', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.036', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.29', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.435', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.20', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.023', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.31', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.12', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.97', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.04', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.75', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.58', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.039', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.42', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.006', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.50', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.65', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.49', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.67', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.36', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.52', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.267', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.35', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.53', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '1.24', 'ciUpperLimit': '1.89', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.70', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '1.25', 'ciUpperLimit': '1.90', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.67', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.056', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.45', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.759', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.26', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.051', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.45', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.30', 'ciUpperLimit': '1.98', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.85', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '1.37', 'ciUpperLimit': '2.05', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.86', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.342', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.35', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.943', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.23', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.126', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.42', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.27', 'ciUpperLimit': '1.98', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.86', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.29', 'ciUpperLimit': '2.00', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.89', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.453', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.34', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.816', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.22', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.384', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.36', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.91', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.82', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.25', 'ciUpperLimit': '1.97', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.82', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.483', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.34', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.991', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.25', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.228', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.41', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.85', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.69', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.90', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.78', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.587', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.33', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.517', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.17', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.360', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.38', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.60', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.57', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.76', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.56', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.811', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.31', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.977', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.28', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.164', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.47', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.43', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.40', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.56', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.46', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.846', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.25', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.702', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.23', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.496', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.38', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.22', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.21', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.26', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.33', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.441', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.17', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.408', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.16', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.652', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.22', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.02', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.95', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.10', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.10', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.567', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.20', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.315', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.14', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.997', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.28', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.77', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.78', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.95', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.92', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.276', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.12', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.318', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.13', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.849', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.30', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.66', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.68', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.79', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.87', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.135', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.06', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.175', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.08', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.590', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.19', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.49', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.261', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.54', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.61', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.72', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.061', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.01', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.138', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.06', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.353', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.13', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[no pain\\] to 3 \\[worst possible pain\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Difference on 11-Point Numerical Scale (PID11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0.25 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '0.5 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '2.3', 'groupId': 'OG003'}, {'value': '1.7', 'spread': '1.8', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '2.6', 'groupId': 'OG004'}]}]}, {'title': '1.5 hour', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '2.7', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '2.5', 'groupId': 'OG003'}, {'value': '5.0', 'spread': '2.8', 'groupId': 'OG004'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '2.7', 'groupId': 'OG003'}, {'value': '5.2', 'spread': '2.9', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '2.7', 'groupId': 'OG003'}, {'value': '5.1', 'spread': '3.0', 'groupId': 'OG004'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '3.0', 'groupId': 'OG003'}, {'value': '4.9', 'spread': '3.0', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '3.1', 'groupId': 'OG003'}, {'value': '4.4', 'spread': '3.2', 'groupId': 'OG004'}]}]}, {'title': '7 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '3.1', 'groupId': 'OG003'}, {'value': '3.9', 'spread': '3.2', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '3.0', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '3.2', 'groupId': 'OG004'}]}]}, {'title': '9 hour', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '3.0', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '3.0', 'groupId': 'OG004'}]}]}, {'title': '10 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '2.9', 'groupId': 'OG003'}, {'value': '2.5', 'spread': '3.0', 'groupId': 'OG004'}]}]}, {'title': '11 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.6', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '2.9', 'groupId': 'OG004'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '2.5', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '2.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.51', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.07', 'ciUpperLimit': '1.31', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.44', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.237', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '1.01', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.024', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.93', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.150', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.73', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.054', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.86', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.89', 'ciLowerLimit': '1.92', 'ciUpperLimit': '3.85', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.52', 'ciLowerLimit': '1.56', 'ciUpperLimit': '3.47', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '1.54', 'ciUpperLimit': '3.47', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.72', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.79', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.021', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.11', 'ciUpperLimit': '1.41', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.027', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.41', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.75', 'ciLowerLimit': '3.65', 'ciUpperLimit': '5.84', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.21', 'ciLowerLimit': '3.13', 'ciUpperLimit': '5.29', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.47', 'ciLowerLimit': '3.37', 'ciUpperLimit': '5.56', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.92', 'ciLowerLimit': '2.83', 'ciUpperLimit': '5.02', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.58', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.442', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '1.02', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.152', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '1.30', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.62', 'ciLowerLimit': '4.52', 'ciUpperLimit': '6.72', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.04', 'ciLowerLimit': '3.96', 'ciUpperLimit': '6.13', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.40', 'ciLowerLimit': '4.30', 'ciUpperLimit': '6.50', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.88', 'ciLowerLimit': '3.78', 'ciUpperLimit': '5.98', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.055', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '1.49', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.666', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.90', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.181', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '1.27', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.86', 'ciLowerLimit': '4.71', 'ciUpperLimit': '7.01', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.43', 'ciLowerLimit': '4.29', 'ciUpperLimit': '6.57', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.79', 'ciLowerLimit': '4.64', 'ciUpperLimit': '6.94', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.34', 'ciLowerLimit': '4.19', 'ciUpperLimit': '6.50', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.200', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '1.31', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.831', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.85', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.268', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '1.24', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.73', 'ciLowerLimit': '4.54', 'ciUpperLimit': '6.91', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.31', 'ciLowerLimit': '4.13', 'ciUpperLimit': '6.48', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.60', 'ciLowerLimit': '4.41', 'ciUpperLimit': '6.78', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.35', 'ciLowerLimit': '4.17', 'ciUpperLimit': '6.54', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.367', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '1.19', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.908', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.75', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.553', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '1.06', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.45', 'ciLowerLimit': '4.22', 'ciUpperLimit': '6.68', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.10', 'ciLowerLimit': '3.88', 'ciUpperLimit': '6.31', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.42', 'ciLowerLimit': '4.19', 'ciUpperLimit': '6.66', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.17', 'ciLowerLimit': '3.94', 'ciUpperLimit': '6.40', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.518', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '1.12', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.860', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.75', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.556', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.10', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.44', 'ciLowerLimit': '4.17', 'ciUpperLimit': '6.71', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.93', 'ciLowerLimit': '3.68', 'ciUpperLimit': '6.19', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.27', 'ciLowerLimit': '4.00', 'ciUpperLimit': '6.54', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.06', 'ciLowerLimit': '3.79', 'ciUpperLimit': '6.34', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.392', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '1.25', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.762', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.72', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.638', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '1.08', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.55', 'ciLowerLimit': '3.20', 'ciUpperLimit': '5.90', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.45', 'ciLowerLimit': '3.11', 'ciUpperLimit': '5.78', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.91', 'ciLowerLimit': '3.56', 'ciUpperLimit': '6.26', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.39', 'ciLowerLimit': '3.04', 'ciUpperLimit': '5.74', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.741', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '1.08', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.907', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.95', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.274', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '1.44', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.77', 'ciLowerLimit': '2.40', 'ciUpperLimit': '5.13', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.91', 'ciLowerLimit': '2.56', 'ciUpperLimit': '5.26', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.12', 'ciLowerLimit': '2.75', 'ciUpperLimit': '5.48', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.01', 'ciLowerLimit': '2.64', 'ciUpperLimit': '5.38', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.607', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.69', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.824', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '0.81', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.827', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '1.04', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.98', 'ciLowerLimit': '1.58', 'ciUpperLimit': '4.39', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.27', 'ciLowerLimit': '1.88', 'ciUpperLimit': '4.65', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.12', 'ciLowerLimit': '1.71', 'ciUpperLimit': '4.52', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.57', 'ciLowerLimit': '2.16', 'ciUpperLimit': '4.98', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.232', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.38', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.522', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-1.24', 'ciUpperLimit': '0.63', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.356', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '0.51', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.31', 'ciLowerLimit': '0.92', 'ciUpperLimit': '3.69', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.45', 'ciLowerLimit': '1.08', 'ciUpperLimit': '3.82', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.70', 'ciLowerLimit': '1.31', 'ciUpperLimit': '4.08', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '1.46', 'ciUpperLimit': '4.23', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.264', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '0.41', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.400', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '0.53', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.758', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '0.80', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.27', 'ciUpperLimit': '2.97', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.55', 'ciUpperLimit': '3.21', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.29', 'ciLowerLimit': '0.94', 'ciUpperLimit': '3.63', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '1.05', 'ciUpperLimit': '3.75', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.097', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '0.14', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.254', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '0.38', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.812', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '0.81', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.03', 'ciUpperLimit': '2.61', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.31', 'ciUpperLimit': '2.87', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.43', 'ciUpperLimit': '3.02', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.08', 'ciLowerLimit': '0.78', 'ciUpperLimit': '3.37', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.094', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '0.13', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.269', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '0.38', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.437', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.53', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '1.92', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.02', 'ciUpperLimit': '2.35', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.13', 'ciUpperLimit': '2.49', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.93', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.01', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '-0.20', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.160', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '0.22', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.284', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.37', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0.25 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '0.5 hour', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '1.8', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '1.4', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '1.9', 'groupId': 'OG003'}, {'value': '3.2', 'spread': '1.9', 'groupId': 'OG004'}]}]}, {'title': '1.5 hour', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '1.8', 'groupId': 'OG003'}, {'value': '3.9', 'spread': '1.9', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '1.9', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '2.1', 'groupId': 'OG004'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '2.2', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '2.3', 'groupId': 'OG004'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '2.3', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '2.3', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '2.5', 'groupId': 'OG004'}]}]}, {'title': '7 hour', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '2.5', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '3.0', 'spread': '2.5', 'groupId': 'OG004'}]}]}, {'title': '9 hour', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '2.3', 'groupId': 'OG003'}, {'value': '2.5', 'spread': '2.4', 'groupId': 'OG004'}]}]}, {'title': '10 hour', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '2.3', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '2.4', 'groupId': 'OG004'}]}]}, {'title': '11 hour', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '2.2', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '2.4', 'groupId': 'OG004'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '2.1', 'groupId': 'OG003'}, {'value': '1.7', 'spread': '2.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.10', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.066', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.94', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.20', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.232', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.78', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.067', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.66', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.354', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.50', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.017', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.76', 'groupDescription': '0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.45', 'ciUpperLimit': '2.86', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.93', 'ciLowerLimit': '1.23', 'ciUpperLimit': '2.64', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.80', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.61', 'ciUpperLimit': '2.02', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.33', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.014', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.12', 'ciUpperLimit': '1.11', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.27', 'groupDescription': '0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.45', 'ciLowerLimit': '2.69', 'ciUpperLimit': '4.22', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '2.36', 'ciUpperLimit': '3.89', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.49', 'ciLowerLimit': '2.72', 'ciUpperLimit': '4.26', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '2.02', 'ciUpperLimit': '3.54', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.21', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.202', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.88', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.24', 'groupDescription': '1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.00', 'ciLowerLimit': '3.24', 'ciUpperLimit': '4.76', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.55', 'ciLowerLimit': '2.79', 'ciUpperLimit': '4.31', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.03', 'ciLowerLimit': '3.27', 'ciUpperLimit': '4.79', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.48', 'ciLowerLimit': '2.72', 'ciUpperLimit': '4.24', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.056', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '1.05', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.789', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.60', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.042', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.08', 'groupDescription': '1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.17', 'ciLowerLimit': '3.37', 'ciUpperLimit': '4.98', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.86', 'ciLowerLimit': '3.06', 'ciUpperLimit': '4.66', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.34', 'ciLowerLimit': '3.54', 'ciUpperLimit': '5.14', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.89', 'ciLowerLimit': '3.09', 'ciUpperLimit': '4.69', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.317', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.85', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.922', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.53', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.112', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '1.02', 'groupDescription': '2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.10', 'ciLowerLimit': '3.27', 'ciUpperLimit': '4.94', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.76', 'ciLowerLimit': '2.92', 'ciUpperLimit': '4.59', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.15', 'ciLowerLimit': '3.32', 'ciUpperLimit': '4.99', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.89', 'ciLowerLimit': '3.05', 'ciUpperLimit': '4.72', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.464', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.81', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.667', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.45', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.368', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.86', 'groupDescription': '3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.94', 'ciLowerLimit': '3.08', 'ciUpperLimit': '4.81', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.63', 'ciLowerLimit': '2.77', 'ciUpperLimit': '4.49', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.06', 'ciLowerLimit': '3.19', 'ciUpperLimit': '4.92', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.68', 'ciLowerLimit': '2.82', 'ciUpperLimit': '4.54', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.397', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.86', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.866', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.55', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.226', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.97', 'groupDescription': '4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.80', 'ciLowerLimit': '2.90', 'ciUpperLimit': '4.70', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.37', 'ciLowerLimit': '2.47', 'ciUpperLimit': '4.26', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.89', 'ciLowerLimit': '2.99', 'ciUpperLimit': '4.79', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.60', 'ciLowerLimit': '2.70', 'ciUpperLimit': '4.50', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.536', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.83', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.467', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.39', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.361', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.92', 'groupDescription': '5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.17', 'ciLowerLimit': '2.21', 'ciUpperLimit': '4.13', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '2.04', 'ciUpperLimit': '3.95', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.51', 'ciLowerLimit': '2.55', 'ciUpperLimit': '4.47', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.04', 'ciLowerLimit': '2.09', 'ciUpperLimit': '4.00', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.704', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.80', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.890', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.62', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.170', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '1.14', 'groupDescription': '6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.69', 'ciLowerLimit': '1.72', 'ciUpperLimit': '3.67', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.58', 'ciLowerLimit': '1.61', 'ciUpperLimit': '3.56', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '2.01', 'ciUpperLimit': '3.97', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.75', 'ciLowerLimit': '1.77', 'ciUpperLimit': '3.72', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.882', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.63', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.640', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.52', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.482', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.93', 'groupDescription': '7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.06', 'ciLowerLimit': '1.07', 'ciUpperLimit': '3.06', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '1.17', 'ciUpperLimit': '3.16', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.25', 'ciUpperLimit': '3.24', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.42', 'ciLowerLimit': '1.43', 'ciUpperLimit': '3.41', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.314', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '0.34', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.469', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.44', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.616', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.52', 'groupDescription': '8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.56', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '0.55', 'ciUpperLimit': '2.53', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '0.95', 'ciUpperLimit': '2.94', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.90', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.330', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.35', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.288', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.32', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.916', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.73', 'groupDescription': '9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.98', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.01', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.62', 'ciUpperLimit': '2.56', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.45', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.171', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.20', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.201', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.23', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.763', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.78', 'groupDescription': '10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '1.61', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.120', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '1.70', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.24', 'ciUpperLimit': '2.15', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.36', 'ciUpperLimit': '2.26', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.054', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '0.01', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.096', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.10', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.724', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.55', 'groupDescription': '11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.345', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '1.30', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.228', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '1.41', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.045', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.78', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.96', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.036', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.04', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.081', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.07', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.556', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.43', 'groupDescription': '12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[no pain\\] to 3 \\[worst possible pain\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0 to 2 hours', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '1.4', 'groupId': 'OG004'}]}]}, {'title': '0 to 6 hours', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '5.4', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '5.0', 'groupId': 'OG003'}, {'value': '8.2', 'spread': '4.9', 'groupId': 'OG004'}]}]}, {'title': '0 to 8 hours', 'categories': [{'measurements': [{'value': '1.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '6.6', 'groupId': 'OG003'}, {'value': '10.4', 'spread': '6.7', 'groupId': 'OG004'}]}]}, {'title': '0 to 12 hours', 'categories': [{'measurements': [{'value': '2.0', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '9.9', 'groupId': 'OG002'}, {'value': '14.1', 'spread': '9.1', 'groupId': 'OG003'}, {'value': '13.0', 'spread': '9.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.53', 'ciLowerLimit': '2.01', 'ciUpperLimit': '3.05', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.23', 'ciLowerLimit': '1.72', 'ciUpperLimit': '2.75', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '2.04', 'ciUpperLimit': '3.08', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '1.57', 'ciUpperLimit': '2.60', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.016', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.81', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.428', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.50', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.84', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.38', 'ciLowerLimit': '6.59', 'ciUpperLimit': '10.18', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.68', 'ciLowerLimit': '5.89', 'ciUpperLimit': '9.47', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.70', 'ciLowerLimit': '6.91', 'ciUpperLimit': '10.50', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.65', 'ciLowerLimit': '5.86', 'ciUpperLimit': '9.44', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.250', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '1.99', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.956', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '1.28', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.099', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '2.31', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.22', 'ciLowerLimit': '7.78', 'ciUpperLimit': '12.66', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.49', 'ciLowerLimit': '7.06', 'ciUpperLimit': '11.92', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.72', 'ciLowerLimit': '8.28', 'ciUpperLimit': '13.15', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.63', 'ciLowerLimit': '7.19', 'ciUpperLimit': '12.06', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.492', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '2.30', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.873', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '1.56', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.210', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '2.79', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.65', 'ciLowerLimit': '8.10', 'ciUpperLimit': '15.20', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.94', 'ciLowerLimit': '7.40', 'ciUpperLimit': '14.48', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.65', 'ciLowerLimit': '9.10', 'ciUpperLimit': '16.20', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.72', 'ciLowerLimit': '8.18', 'ciUpperLimit': '15.26', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.957', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '2.42', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.534', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '1.69', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.462', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '3.41', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose', 'description': 'Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[none\\] to 3 \\[severe\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0 to 2 hours', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '8.6', 'spread': '4.0', 'groupId': 'OG003'}, {'value': '7.2', 'spread': '4.3', 'groupId': 'OG004'}]}]}, {'title': '0 to 6 hours', 'categories': [{'measurements': [{'value': '1.1', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '29.9', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '28.8', 'spread': '16.1', 'groupId': 'OG002'}, {'value': '30.1', 'spread': '14.4', 'groupId': 'OG003'}, {'value': '26.8', 'spread': '15.0', 'groupId': 'OG004'}]}]}, {'title': '0 to 8 hours', 'categories': [{'measurements': [{'value': '1.8', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '37.6', 'spread': '19.3', 'groupId': 'OG003'}, {'value': '34.2', 'spread': '20.3', 'groupId': 'OG004'}]}]}, {'title': '0 to12 hours', 'categories': [{'measurements': [{'value': '4.1', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '44.0', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '44.5', 'spread': '29.7', 'groupId': 'OG002'}, {'value': '46.5', 'spread': '27.3', 'groupId': 'OG003'}, {'value': '43.7', 'spread': '29.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.06', 'ciLowerLimit': '7.23', 'ciUpperLimit': '10.89', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.14', 'ciLowerLimit': '6.33', 'ciUpperLimit': '9.95', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.66', 'ciLowerLimit': '6.83', 'ciUpperLimit': '10.49', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.61', 'ciLowerLimit': '5.78', 'ciUpperLimit': '9.44', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.024', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.19', 'ciUpperLimit': '2.70', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.392', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '1.76', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.101', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '2.30', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.23', 'ciLowerLimit': '23.97', 'ciUpperLimit': '36.48', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.93', 'ciLowerLimit': '21.74', 'ciUpperLimit': '34.11', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.86', 'ciLowerLimit': '23.60', 'ciUpperLimit': '36.12', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.59', 'ciLowerLimit': '21.33', 'ciUpperLimit': '33.86', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.228', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '6.92', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.875', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-3.84', 'ciUpperLimit': '4.51', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.299', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.27', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '6.55', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.98', 'ciLowerLimit': '28.48', 'ciUpperLimit': '45.47', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.10', 'ciLowerLimit': '26.70', 'ciUpperLimit': '43.50', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.09', 'ciLowerLimit': '28.60', 'ciUpperLimit': '45.59', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.17', 'ciLowerLimit': '26.67', 'ciUpperLimit': '43.68', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.543', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '-4.02', 'ciUpperLimit': '7.63', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.979', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-5.75', 'ciUpperLimit': '5.60', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.517', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '-3.90', 'ciUpperLimit': '7.74', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.96', 'ciLowerLimit': '30.51', 'ciUpperLimit': '55.41', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.20', 'ciLowerLimit': '29.90', 'ciUpperLimit': '54.51', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.12', 'ciLowerLimit': '32.67', 'ciUpperLimit': '57.57', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.25', 'ciLowerLimit': '31.79', 'ciUpperLimit': '56.71', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.767', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-9.82', 'ciUpperLimit': '7.25', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.629', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-10.36', 'ciUpperLimit': '6.27', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.841', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-7.66', 'ciUpperLimit': '9.39', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose', 'description': 'Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0 to 2 hours', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '1.8', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '1.8', 'groupId': 'OG004'}]}]}, {'title': '0 to 6 hours', 'categories': [{'measurements': [{'value': '2.8', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '6.3', 'groupId': 'OG003'}, {'value': '14.3', 'spread': '6.7', 'groupId': 'OG004'}]}]}, {'title': '0 to 8 hours', 'categories': [{'measurements': [{'value': '4.0', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '18.9', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '20.2', 'spread': '8.6', 'groupId': 'OG003'}, {'value': '18.4', 'spread': '9.2', 'groupId': 'OG004'}]}]}, {'title': '0 to 12 hours', 'categories': [{'measurements': [{'value': '6.4', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '12.6', 'groupId': 'OG002'}, {'value': '25.8', 'spread': '12.9', 'groupId': 'OG003'}, {'value': '23.9', 'spread': '13.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.97', 'ciLowerLimit': '3.22', 'ciUpperLimit': '4.73', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.64', 'ciLowerLimit': '2.88', 'ciUpperLimit': '4.39', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.07', 'ciLowerLimit': '3.32', 'ciUpperLimit': '4.83', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.39', 'ciLowerLimit': '2.64', 'ciUpperLimit': '4.14', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.05', 'ciUpperLimit': '1.11', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.360', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.77', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.011', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.15', 'ciUpperLimit': '1.21', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.14', 'ciLowerLimit': '10.54', 'ciUpperLimit': '15.73', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.94', 'ciLowerLimit': '9.35', 'ciUpperLimit': '14.52', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.54', 'ciLowerLimit': '10.95', 'ciUpperLimit': '16.13', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.04', 'ciLowerLimit': '9.45', 'ciUpperLimit': '14.63', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.235', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '2.91', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.910', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-1.91', 'ciUpperLimit': '1.70', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.105', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '3.31', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.05', 'ciLowerLimit': '12.49', 'ciUpperLimit': '19.61', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.88', 'ciLowerLimit': '11.33', 'ciUpperLimit': '18.43', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.76', 'ciLowerLimit': '13.20', 'ciUpperLimit': '20.32', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.23', 'ciLowerLimit': '11.68', 'ciUpperLimit': '18.78', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.514', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '3.32', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.783', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '2.13', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.227', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '4.02', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.28', 'ciLowerLimit': '12.95', 'ciUpperLimit': '23.61', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.30', 'ciLowerLimit': '11.99', 'ciUpperLimit': '22.61', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.45', 'ciLowerLimit': '15.13', 'ciUpperLimit': '25.78', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.92', 'ciLowerLimit': '13.61', 'ciUpperLimit': '24.24', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.736', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-4.37', 'ciUpperLimit': '3.09', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.390', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.62', 'ciLowerLimit': '-5.32', 'ciUpperLimit': '2.08', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.420', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '-2.19', 'ciUpperLimit': '5.26', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose', 'description': 'TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0 to 2 hours', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '3.1', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': '0 to 6 hours', 'categories': [{'measurements': [{'value': '3.5', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '23.3', 'spread': '11.6', 'groupId': 'OG002'}, {'value': '25.3', 'spread': '10.9', 'groupId': 'OG003'}, {'value': '22.5', 'spread': '11.2', 'groupId': 'OG004'}]}]}, {'title': '0 to 12 hours', 'categories': [{'measurements': [{'value': '8.4', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '36.3', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '39.9', 'spread': '21.1', 'groupId': 'OG003'}, {'value': '36.9', 'spread': '22.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.50', 'ciLowerLimit': '5.25', 'ciUpperLimit': '7.76', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.87', 'ciLowerLimit': '4.62', 'ciUpperLimit': '7.11', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.63', 'ciLowerLimit': '5.38', 'ciUpperLimit': '7.88', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.48', 'ciLowerLimit': '4.23', 'ciUpperLimit': '6.73', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.15', 'ciUpperLimit': '1.90', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.380', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.26', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.28', 'ciUpperLimit': '2.03', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.52', 'ciLowerLimit': '17.17', 'ciUpperLimit': '25.87', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.62', 'ciLowerLimit': '15.29', 'ciUpperLimit': '23.95', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.24', 'ciLowerLimit': '17.89', 'ciUpperLimit': '26.59', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.69', 'ciLowerLimit': '15.35', 'ciUpperLimit': '24.02', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.237', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '4.88', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.965', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '2.95', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.099', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '5.60', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.93', 'ciLowerLimit': '21.14', 'ciUpperLimit': '38.73', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.24', 'ciLowerLimit': '19.48', 'ciUpperLimit': '37.00', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.10', 'ciLowerLimit': '24.31', 'ciUpperLimit': '41.89', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.64', 'ciLowerLimit': '21.87', 'ciUpperLimit': '39.41', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.821', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-6.86', 'ciUpperLimit': '5.44', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.440', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-8.51', 'ciUpperLimit': '3.71', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.432', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.46', 'ciLowerLimit': '-3.69', 'ciUpperLimit': '8.61', 'pValueComment': 'p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.', 'groupDescription': '0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose', 'description': 'SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 \\[none\\] to 3 \\[severe\\]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Participants With Meaningful Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0.25 hours', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}]}]}, {'title': '0.5 hours', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '23.7', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}, {'value': '13.0', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '65.6', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}, {'value': '67.4', 'groupId': 'OG003'}, {'value': '54.3', 'groupId': 'OG004'}]}]}, {'title': '1.5 hours', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '81.1', 'groupId': 'OG001'}, {'value': '69.9', 'groupId': 'OG002'}, {'value': '77.5', 'groupId': 'OG003'}, {'value': '66.3', 'groupId': 'OG004'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '85.6', 'groupId': 'OG001'}, {'value': '77.4', 'groupId': 'OG002'}, {'value': '84.3', 'groupId': 'OG003'}, {'value': '73.9', 'groupId': 'OG004'}]}]}, {'title': '3 hours', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}, {'value': '81.7', 'groupId': 'OG002'}, {'value': '88.8', 'groupId': 'OG003'}, {'value': '80.4', 'groupId': 'OG004'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}, {'value': '83.9', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '81.5', 'groupId': 'OG004'}]}]}, {'title': '5 hours', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '84.9', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '82.6', 'groupId': 'OG004'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '86.0', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '83.7', 'groupId': 'OG004'}]}]}, {'title': '7 hours', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '87.1', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '84.8', 'groupId': 'OG004'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '9 hours', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '10 hours', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '11 hours', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.571', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '3.20', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.593', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '2.90', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.282', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '7.68', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.552', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '3.42', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.994', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-3.13', 'ciUpperLimit': '3.11', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.879', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-3.26', 'ciUpperLimit': '2.80', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.280', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '-1.98', 'ciUpperLimit': '6.64', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.67', 'ciLowerLimit': '24.54', 'ciUpperLimit': '42.81', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.34', 'ciLowerLimit': '14.93', 'ciUpperLimit': '31.75', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.28', 'ciLowerLimit': '13.55', 'ciUpperLimit': '31.00', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.39', 'ciLowerLimit': '6.28', 'ciUpperLimit': '20.50', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.14', 'ciLowerLimit': '8.67', 'ciUpperLimit': '31.62', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.088', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.56', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '20.51', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.100', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.36', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '20.45', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '62.54', 'ciLowerLimit': '50.93', 'ciUpperLimit': '74.15', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.66', 'ciLowerLimit': '39.50', 'ciUpperLimit': '63.82', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.68', 'ciLowerLimit': '52.92', 'ciUpperLimit': '76.43', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.03', 'ciLowerLimit': '40.43', 'ciUpperLimit': '63.63', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.138', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.66', 'ciLowerLimit': '-3.04', 'ciUpperLimit': '24.35', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.935', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-14.71', 'ciUpperLimit': '13.52', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.063', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.30', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '27.17', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.68', 'ciLowerLimit': '62.82', 'ciUpperLimit': '86.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.18', 'ciLowerLimit': '50.42', 'ciUpperLimit': '75.95', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.39', 'ciLowerLimit': '59.21', 'ciUpperLimit': '83.57', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.50', 'ciLowerLimit': '47.89', 'ciUpperLimit': '73.11', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.027', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.43', 'ciLowerLimit': '1.97', 'ciUpperLimit': '26.89', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.729', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.35', 'ciLowerLimit': '-10.91', 'ciUpperLimit': '15.61', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.087', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.33', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '24.21', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '75.60', 'ciLowerLimit': '62.50', 'ciUpperLimit': '88.70', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.45', 'ciLowerLimit': '53.65', 'ciUpperLimit': '81.24', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.46', 'ciLowerLimit': '61.21', 'ciUpperLimit': '87.70', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.23', 'ciLowerLimit': '50.30', 'ciUpperLimit': '78.17', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.052', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.59', 'ciLowerLimit': '0.12', 'ciUpperLimit': '23.06', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.652', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84', 'ciLowerLimit': '-9.49', 'ciUpperLimit': '15.16', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.090', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.28', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '22.03', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '79.93', 'ciLowerLimit': '67.41', 'ciUpperLimit': '92.46', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.65', 'ciLowerLimit': '58.25', 'ciUpperLimit': '85.05', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '78.92', 'ciLowerLimit': '66.29', 'ciUpperLimit': '91.56', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70.56', 'ciLowerLimit': '57.04', 'ciUpperLimit': '84.07', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.069', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.61', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '19.80', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.911', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-10.73', 'ciUpperLimit': '12.03', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.127', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.27', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '18.77', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.55', 'ciLowerLimit': '62.37', 'ciUpperLimit': '90.72', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70.60', 'ciLowerLimit': '55.93', 'ciUpperLimit': '85.28', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.50', 'ciLowerLimit': '62.22', 'ciUpperLimit': '90.79', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.05', 'ciLowerLimit': '53.02', 'ciUpperLimit': '83.09', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.098', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.57', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '18.61', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.721', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '-9.02', 'ciUpperLimit': '13.04', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.115', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.28', 'ciLowerLimit': '-1.85', 'ciUpperLimit': '18.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.66', 'ciLowerLimit': '63.63', 'ciUpperLimit': '91.69', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.65', 'ciLowerLimit': '57.07', 'ciUpperLimit': '86.22', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.50', 'ciLowerLimit': '62.22', 'ciUpperLimit': '90.79', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.10', 'ciLowerLimit': '54.14', 'ciUpperLimit': '84.06', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.086', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.56', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '18.27', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.714', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '-8.76', 'ciUpperLimit': '12.77', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.164', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.21', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '17.22', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.38', 'ciLowerLimit': '59.56', 'ciUpperLimit': '89.20', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.50', 'ciLowerLimit': '54.29', 'ciUpperLimit': '84.70', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.24', 'ciLowerLimit': '58.18', 'ciUpperLimit': '88.30', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.00', 'ciLowerLimit': '51.40', 'ciUpperLimit': '82.61', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.129', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.46', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '17.04', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.712', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-8.50', 'ciUpperLimit': '12.43', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.229', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.12', 'ciLowerLimit': '-3.76', 'ciUpperLimit': '16.00', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.38', 'ciLowerLimit': '59.56', 'ciUpperLimit': '89.20', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70.54', 'ciLowerLimit': '55.45', 'ciUpperLimit': '85.64', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.24', 'ciLowerLimit': '58.18', 'ciUpperLimit': '88.30', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.05', 'ciLowerLimit': '52.53', 'ciUpperLimit': '83.57', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.186', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.38', 'ciLowerLimit': '-3.05', 'ciUpperLimit': '15.81', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.703', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-8.18', 'ciUpperLimit': '12.12', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.312', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.06', 'ciLowerLimit': '-4.68', 'ciUpperLimit': '14.79', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.38', 'ciLowerLimit': '59.56', 'ciUpperLimit': '89.20', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.59', 'ciLowerLimit': '56.61', 'ciUpperLimit': '86.57', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.24', 'ciLowerLimit': '58.18', 'ciUpperLimit': '88.30', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.21', 'ciLowerLimit': '53.86', 'ciUpperLimit': '84.56', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.38', 'ciLowerLimit': '59.56', 'ciUpperLimit': '89.20', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.59', 'ciLowerLimit': '56.61', 'ciUpperLimit': '86.57', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.24', 'ciLowerLimit': '58.18', 'ciUpperLimit': '88.30', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.21', 'ciLowerLimit': '53.86', 'ciUpperLimit': '84.56', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Participants With Confirmed First Perceptible Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '0.25 hour', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}, {'value': '28.1', 'groupId': 'OG003'}, {'value': '19.6', 'groupId': 'OG004'}]}]}, {'title': '0.5 hour', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '77.5', 'groupId': 'OG003'}, {'value': '63.0', 'groupId': 'OG004'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}, {'value': '83.9', 'groupId': 'OG002'}, {'value': '88.8', 'groupId': 'OG003'}, {'value': '80.4', 'groupId': 'OG004'}]}]}, {'title': '1.5 hour', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '86.0', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '84.8', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '7 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '9 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '10 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '11 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '89.9', 'groupId': 'OG003'}, {'value': '85.9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.99', 'ciLowerLimit': '13.32', 'ciUpperLimit': '34.67', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.83', 'ciLowerLimit': '4.59', 'ciUpperLimit': '25.07', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.98', 'ciLowerLimit': '13.43', 'ciUpperLimit': '36.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.57', 'ciLowerLimit': '6.25', 'ciUpperLimit': '26.88', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.269', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.86', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '18.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.735', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-13.34', 'ciUpperLimit': '9.43', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.176', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.58', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '21.04', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.30', 'ciLowerLimit': '49.07', 'ciUpperLimit': '77.52', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.81', 'ciLowerLimit': '42.28', 'ciUpperLimit': '71.34', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.57', 'ciLowerLimit': '53.58', 'ciUpperLimit': '81.55', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.31', 'ciLowerLimit': '38.62', 'ciUpperLimit': '67.99', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.140', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.28', 'ciLowerLimit': '-3.26', 'ciUpperLimit': '23.82', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.674', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.98', 'ciLowerLimit': '-10.94', 'ciUpperLimit': '16.89', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.034', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.58', 'ciLowerLimit': '1.22', 'ciUpperLimit': '27.93', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.32', 'ciLowerLimit': '58.25', 'ciUpperLimit': '86.39', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.20', 'ciLowerLimit': '52.63', 'ciUpperLimit': '81.78', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.40', 'ciLowerLimit': '58.40', 'ciUpperLimit': '86.40', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.12', 'ciLowerLimit': '49.32', 'ciUpperLimit': '78.91', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.119', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.40', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '18.85', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.616', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84', 'ciLowerLimit': '-8.30', 'ciUpperLimit': '13.98', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.125', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.34', 'ciLowerLimit': '-2.20', 'ciUpperLimit': '18.87', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.49', 'ciLowerLimit': '60.73', 'ciUpperLimit': '88.25', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.38', 'ciLowerLimit': '55.05', 'ciUpperLimit': '83.71', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.52', 'ciLowerLimit': '59.65', 'ciUpperLimit': '87.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.36', 'ciLowerLimit': '54.01', 'ciUpperLimit': '82.71', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.187', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.33', 'ciLowerLimit': '-2.99', 'ciUpperLimit': '15.65', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.881', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '-9.42', 'ciUpperLimit': '10.99', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.311', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.05', 'ciLowerLimit': '-4.60', 'ciUpperLimit': '14.71', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.10', 'ciLowerLimit': '55.82', 'ciUpperLimit': '86.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.31', 'ciLowerLimit': '52.88', 'ciUpperLimit': '83.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.98', 'ciLowerLimit': '54.47', 'ciUpperLimit': '85.48', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.95', 'ciLowerLimit': '50.16', 'ciUpperLimit': '81.74', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.265', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.25', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '14.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.710', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '-7.82', 'ciUpperLimit': '11.53', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.416', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.99', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '13.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': "Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.8'}, {'value': '9.7', 'comment': 'Upper limit of confidence interval was not estimable as it was \\>720 minutes/12 hours) for Ibuprofen 200 mg + Acetaminophen 500 mg group.', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': 'NA'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '12'}, {'value': '11.1', 'comment': 'Upper limit of confidence interval was not estimable as it was \\>720 minutes/12 hours) for Ibuprofen 300 mg + Acetaminophen 500 mg group.', 'groupId': 'OG003', 'lowerLimit': '9.2', 'upperLimit': 'NA'}, {'value': '10.4', 'comment': 'Upper limit of confidence interval was not estimable as it was \\>720 minutes/12 hours) for Ibuprofen 400 mg group.', 'groupId': 'OG004', 'lowerLimit': '9.2', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.45', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.39', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.35', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.41', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.549', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.63', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.863', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.42', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.454', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.28', 'pValueComment': 'p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.', 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From 0 hour up to 12 hours post-dose', 'description': 'Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Participants With Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'title': '1.5 hour', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}, {'value': '5.4', 'groupId': 'OG004'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}, {'value': '5.6', 'groupId': 'OG003'}, {'value': '10.9', 'groupId': 'OG004'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '8.6', 'groupId': 'OG002'}, {'value': '6.7', 'groupId': 'OG003'}, {'value': '13.0', 'groupId': 'OG004'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}, {'value': '7.9', 'groupId': 'OG003'}, {'value': '15.2', 'groupId': 'OG004'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '14.0', 'groupId': 'OG002'}, {'value': '10.1', 'groupId': 'OG003'}, {'value': '15.2', 'groupId': 'OG004'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}, {'value': '14.6', 'groupId': 'OG003'}, {'value': '20.7', 'groupId': 'OG004'}]}]}, {'title': '7 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}, {'value': '20.4', 'groupId': 'OG002'}, {'value': '15.7', 'groupId': 'OG003'}, {'value': '27.2', 'groupId': 'OG004'}]}]}, {'title': '8 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '28.9', 'groupId': 'OG001'}, {'value': '23.7', 'groupId': 'OG002'}, {'value': '25.8', 'groupId': 'OG003'}, {'value': '32.6', 'groupId': 'OG004'}]}]}, {'title': '9 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '36.0', 'groupId': 'OG003'}, {'value': '35.9', 'groupId': 'OG004'}]}]}, {'title': '10 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}, {'value': '42.7', 'groupId': 'OG003'}, {'value': '45.7', 'groupId': 'OG004'}]}]}, {'title': '11 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '57.8', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}, {'value': '48.3', 'groupId': 'OG003'}, {'value': '53.3', 'groupId': 'OG004'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}, {'value': '57.0', 'groupId': 'OG002'}, {'value': '50.6', 'groupId': 'OG003'}, {'value': '55.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.07', 'ciLowerLimit': '-59.56', 'ciUpperLimit': '-22.58', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.98', 'ciLowerLimit': '-59.41', 'ciUpperLimit': '-22.56', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.64', 'ciLowerLimit': '-57.49', 'ciUpperLimit': '-19.79', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.11', 'ciLowerLimit': '-56.94', 'ciUpperLimit': '-19.28', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.274', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.13', 'ciLowerLimit': '-8.67', 'ciUpperLimit': '2.40', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.304', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.89', 'ciLowerLimit': '-8.40', 'ciUpperLimit': '2.62', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.769', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-7.41', 'ciUpperLimit': '5.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-71.19', 'ciLowerLimit': '-88.00', 'ciUpperLimit': '-54.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-66.99', 'ciLowerLimit': '-84.26', 'ciUpperLimit': '-49.72', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-67.47', 'ciLowerLimit': '-84.75', 'ciUpperLimit': '-50.19', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.76', 'ciLowerLimit': '-80.45', 'ciUpperLimit': '-45.07', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.021', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.53', 'ciLowerLimit': '-15.55', 'ciUpperLimit': '-1.50', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.337', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.99', 'ciLowerLimit': '-12.05', 'ciUpperLimit': '4.07', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.204', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.26', 'ciLowerLimit': '-13.28', 'ciUpperLimit': '2.76', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-77.89', 'ciLowerLimit': '-92.29', 'ciUpperLimit': '-63.49', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-71.65', 'ciLowerLimit': '-86.71', 'ciUpperLimit': '-56.58', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-72.87', 'ciLowerLimit': '-88.06', 'ciUpperLimit': '-57.68', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-67.20', 'ciLowerLimit': '-82.87', 'ciUpperLimit': '-51.52', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.71', 'ciLowerLimit': '-18.20', 'ciUpperLimit': '-3.21', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.385', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.99', 'ciLowerLimit': '-12.86', 'ciUpperLimit': '4.88', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.162', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.29', 'ciLowerLimit': '-14.97', 'ciUpperLimit': '2.40', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-76.81', 'ciLowerLimit': '-91.35', 'ciUpperLimit': '-62.27', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.60', 'ciLowerLimit': '-85.79', 'ciUpperLimit': '-55.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-71.66', 'ciLowerLimit': '-87.00', 'ciUpperLimit': '-56.31', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-65.19', 'ciLowerLimit': '-81.03', 'ciUpperLimit': '-49.34', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.70', 'ciLowerLimit': '-19.86', 'ciUpperLimit': '-3.55', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.310', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.94', 'ciLowerLimit': '-14.34', 'ciUpperLimit': '4.46', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.126', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.36', 'ciLowerLimit': '-16.63', 'ciUpperLimit': '1.90', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-75.64', 'ciLowerLimit': '-90.35', 'ciUpperLimit': '-60.93', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-66.43', 'ciLowerLimit': '-81.99', 'ciUpperLimit': '-50.88', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-69.33', 'ciLowerLimit': '-84.96', 'ciUpperLimit': '-53.71', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-65.19', 'ciLowerLimit': '-81.03', 'ciUpperLimit': '-49.34', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.016', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.61', 'ciLowerLimit': '-19.02', 'ciUpperLimit': '-2.19', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.895', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-10.69', 'ciUpperLimit': '9.32', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.308', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.09', 'ciLowerLimit': '-14.80', 'ciUpperLimit': '4.62', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-71.36', 'ciLowerLimit': '-86.58', 'ciUpperLimit': '-56.13', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.11', 'ciLowerLimit': '-78.04', 'ciUpperLimit': '-46.19', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-64.57', 'ciLowerLimit': '-80.64', 'ciUpperLimit': '-48.50', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59.84', 'ciLowerLimit': '-76.12', 'ciUpperLimit': '-43.55', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.028', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.49', 'ciLowerLimit': '-21.63', 'ciUpperLimit': '-1.35', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.747', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.88', 'ciLowerLimit': '-13.15', 'ciUpperLimit': '9.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.303', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.88', 'ciLowerLimit': '-16.88', 'ciUpperLimit': '5.12', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.49', 'ciLowerLimit': '-78.64', 'ciUpperLimit': '-46.34', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-60.09', 'ciLowerLimit': '-76.15', 'ciUpperLimit': '-44.02', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-63.45', 'ciLowerLimit': '-79.64', 'ciUpperLimit': '-47.27', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.41', 'ciLowerLimit': '-70.10', 'ciUpperLimit': '-36.72', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.137', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.14', 'ciLowerLimit': '-21.18', 'ciUpperLimit': '2.90', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.311', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.34', 'ciLowerLimit': '-18.39', 'ciUpperLimit': '5.71', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.067', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.23', 'ciLowerLimit': '-22.97', 'ciUpperLimit': '0.52', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.54', 'ciLowerLimit': '-68.42', 'ciUpperLimit': '-34.66', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.01', 'ciLowerLimit': '-73.27', 'ciUpperLimit': '-40.76', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.21', 'ciLowerLimit': '-70.16', 'ciUpperLimit': '-36.26', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.82', 'ciLowerLimit': '-64.81', 'ciUpperLimit': '-30.83', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.604', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.52', 'ciLowerLimit': '-16.89', 'ciUpperLimit': '9.85', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.184', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.78', 'ciLowerLimit': '-21.50', 'ciUpperLimit': '3.94', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.340', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.43', 'ciLowerLimit': '-19.56', 'ciUpperLimit': '6.70', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.27', 'ciLowerLimit': '-57.67', 'ciUpperLimit': '-22.88', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.24', 'ciLowerLimit': '-64.21', 'ciUpperLimit': '-30.27', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.15', 'ciLowerLimit': '-60.57', 'ciUpperLimit': '-25.72', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.45', 'ciLowerLimit': '-61.55', 'ciUpperLimit': '-27.34', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.548', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.29', 'ciLowerLimit': '-9.80', 'ciUpperLimit': '18.38', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.721', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.51', 'ciLowerLimit': '-16.20', 'ciUpperLimit': '11.18', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.951', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-13.47', 'ciUpperLimit': '14.35', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.13', 'ciLowerLimit': '-46.66', 'ciUpperLimit': '-11.59', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.30', 'ciLowerLimit': '-51.62', 'ciUpperLimit': '-16.97', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.26', 'ciLowerLimit': '-53.80', 'ciUpperLimit': '-18.73', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.56', 'ciLowerLimit': '-51.77', 'ciUpperLimit': '-17.35', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.455', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.45', 'ciLowerLimit': '-8.89', 'ciUpperLimit': '19.79', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.953', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-13.80', 'ciUpperLimit': '14.65', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.731', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.48', 'ciLowerLimit': '-16.63', 'ciUpperLimit': '11.66', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.63', 'ciLowerLimit': '-39.97', 'ciUpperLimit': '-5.29', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.87', 'ciLowerLimit': '-44.12', 'ciUpperLimit': '-9.62', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.76', 'ciLowerLimit': '-48.36', 'ciUpperLimit': '-13.16', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.26', 'ciLowerLimit': '-44.51', 'ciUpperLimit': '-10.00', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.516', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.66', 'ciLowerLimit': '-9.50', 'ciUpperLimit': '18.82', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.939', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-13.63', 'ciUpperLimit': '14.72', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.536', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.53', 'ciLowerLimit': '-18.86', 'ciUpperLimit': '9.80', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.81', 'ciLowerLimit': '-33.02', 'ciUpperLimit': '1.41', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.71', 'ciLowerLimit': '-40.91', 'ciUpperLimit': '-6.51', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.44', 'ciLowerLimit': '-45.99', 'ciUpperLimit': '-10.88', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.04', 'ciLowerLimit': '-42.23', 'ciUpperLimit': '-7.85', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.195', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.16', 'ciLowerLimit': '-4.75', 'ciUpperLimit': '23.08', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.835', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '-12.54', 'ciUpperLimit': '15.50', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.542', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.41', 'ciLowerLimit': '-18.61', 'ciUpperLimit': '9.79', 'pValueComment': 'p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.', 'groupDescription': '12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Participant Global Evaluation of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'OG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'OG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '1.2', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '1.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.01', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.01', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.99', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.95', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.174', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.37', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.722', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.26', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.365', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.11', 'pValueComment': 'p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).', 'groupDescription': 'Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '12 hour', 'description': 'Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received study medication and provided a baseline assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'FG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'FG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'FG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'FG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '89'}, {'groupId': 'FG004', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '88'}, {'groupId': 'FG004', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}, {'value': '394', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received Placebo as single oral dose caplets during the 12 hours study.'}, {'id': 'BG001', 'title': 'Ibuprofen 200 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'BG002', 'title': 'Ibuprofen 250 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'BG003', 'title': 'Ibuprofen 300 mg + Acetaminophen 500 mg', 'description': 'Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.'}, {'id': 'BG004', 'title': 'Ibuprofen 400 mg', 'description': 'Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '17.7', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '18.4', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '17.8', 'spread': '1.8', 'groupId': 'BG003'}, {'value': '18.4', 'spread': '1.9', 'groupId': 'BG004'}, {'value': '18.1', 'spread': '2.0', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '200', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '194', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2014-07-25', 'completionDateStruct': {'date': '2012-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2012-03-19', 'dispFirstSubmitQcDate': '2014-07-25', 'resultsFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2012-03-19', 'dispFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-05', 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)', 'timeFrame': 'From 0 hour up to 8 hours post-dose', 'description': 'SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[none\\] to 3 \\[severe\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.'}], 'secondaryOutcomes': [{'measure': 'Time to Onset of Meaningful Pain Relief', 'timeFrame': 'From 0 hour up to 12 hours post-dose', 'description': 'Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.'}, {'measure': 'Time to Confirmed First Perceptible Relief', 'timeFrame': 'From 0 hour up to 12 hours post-dose', 'description': "Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation)."}, {'measure': 'Pain Relief Rating Score (PRR)', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'Participants answered a question: "how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.'}, {'measure': 'Pain Intensity Difference on 4-Point Categorical Scale (PID4)', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[no pain\\] to 3 \\[worst possible pain\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).'}, {'measure': 'Pain Intensity Difference on 11-Point Numerical Scale (PID11)', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).'}, {'measure': 'Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[no pain\\] to 3 \\[worst possible pain\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.'}, {'measure': 'Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose', 'description': 'Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \\[none\\] to 3 \\[severe\\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).'}, {'measure': 'Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose', 'description': 'Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).'}, {'measure': 'Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose', 'description': 'TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief.'}, {'measure': 'Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose', 'timeFrame': '0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose', 'description': 'SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 \\[none\\] to 3 \\[severe\\]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.'}, {'measure': 'Cumulative Percentage of Participants With Meaningful Relief', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.'}, {'measure': 'Cumulative Percentage of Participants With Confirmed First Perceptible Relief', 'timeFrame': '0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': "Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'From 0 hour up to 12 hours post-dose', 'description': 'Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.'}, {'measure': 'Cumulative Percentage of Participants With Treatment Failure', 'timeFrame': '1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose', 'description': 'Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.'}, {'measure': 'Participant Global Evaluation of Study Medication', 'timeFrame': '12 hour', 'description': 'Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ibuprofen', 'acetaminophen', 'pain', 'molar extraction'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '32506309', 'type': 'DERIVED', 'citation': 'Kellstein D, Leyva R. Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study. Drugs R D. 2020 Sep;20(3):237-247. doi: 10.1007/s40268-020-00310-7.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5061001&StudyName=Evaluation%20of%20the%20Efficacy%20of%20Novel%20Ibuprofen%20Acetaminophen%20Combination%20Formulations%20in%20the%20Treatment%20of%20Post-surgical%20Dental%20Pain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females 16 to 40 years of age\n* Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth\n\nExclusion Criteria:\n\n* Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder\n* Pregnant or breastfeeding females'}, 'identificationModule': {'nctId': 'NCT01559259', 'briefTitle': 'Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN', 'orgStudyIdInfo': {'id': 'B5061001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen/acetaminophen (lower dose)', 'interventionNames': ['Drug: Ibuprofen/acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Ibuprofen/acetaminophen (middle dose)', 'interventionNames': ['Drug: Ibuprofen/acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Ibuprofen/acetaminophen (high dose)', 'interventionNames': ['Drug: Ibuprofen/acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ibuprofen/acetaminophen', 'type': 'DRUG', 'description': 'Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg', 'armGroupLabels': ['Ibuprofen/acetaminophen (lower dose)']}, {'name': 'Ibuprofen/acetaminophen', 'type': 'DRUG', 'description': 'Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg', 'armGroupLabels': ['Ibuprofen/acetaminophen (middle dose)']}, {'name': 'Ibuprofen/acetaminophen', 'type': 'DRUG', 'description': 'Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg', 'armGroupLabels': ['Ibuprofen/acetaminophen (high dose)']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'Two caplets of ibuprofen 200 mg', 'armGroupLabels': ['Ibuprofen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two caplets of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}