Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 3:29 PM
Study NCT ID:
NCT01945034
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
5% Topical Ibuprofen (IBU) for Ankle Sprain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, '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': {'timeFrame': 'Baseline up to 14 days after last study drug dose administration (Day 10)', 'eventGroups': [{'id': 'EG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.', 'otherNumAtRisk': 67, 'otherNumAffected': 4, 'seriousNumAtRisk': 67, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.', 'otherNumAtRisk': 85, 'otherNumAffected': 5, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.', 'otherNumAtRisk': 152, 'otherNumAffected': 13, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metatarsalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sticky skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '188.9', 'spread': '14.81', 'groupId': 'OG000'}, {'value': '173.6', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '165.9', 'spread': '10.34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.190', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23', 'ciLowerLimit': '-11.49', 'ciUpperLimit': '57.56', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.633', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '-24.20', 'ciUpperLimit': '39.70', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-53.87', 'ciUpperLimit': '23.30', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 3 Days (0-72 hours)', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'PRIMARY', 'title': 'Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '4.62', 'groupId': 'OG001'}, {'value': '42.1', 'spread': '3.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.426', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '-6.98', 'ciUpperLimit': '16.49', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.850', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-11.90', 'ciUpperLimit': '9.82', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.385', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-18.91', 'ciUpperLimit': '7.32', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 24 hours', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '4.29', 'groupId': 'OG001'}, {'value': '34.7', 'spread': '3.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.072', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '20.91', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.296', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-15.40', 'ciUpperLimit': '4.70', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-27.53', 'ciUpperLimit': '-3.16', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 24 hours', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'Change at: Day 3', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Day 10', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.305', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.30', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.261', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.29', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.996', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.22', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.210', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.36', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.556', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.27', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.17', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 3, 10', 'description': "Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'Change at: Day 3', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Day 10', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.354', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.10', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.237', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.07', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.871', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.19', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.050', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.00', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.640', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.15', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.180', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.41', 'pValueComment': 'p-value \\<=0.05 for treatment effects', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 3, 10', 'description': "The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'Change at: At Rest 1 hour Day 1', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing 1 hour Day 1', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest 2 hour Day 1', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing 2 hour Day 1', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest 3 hour Day 1', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing 3 hour Day 1', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest 4 hour Day 1', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing 4 hour Day 1', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest 5 hour Day 1', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Upon Weight Bearing: 5 hour Day 1', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest 6 hour Day 1', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing 6 hour Day 1', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 1(PM)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 1(PM)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 2(AM)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 2(AM)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 2 Mid-day', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 2 Mid-day', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 2(PM)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 2(PM)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 3(AM)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 3(AM)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 3(AM + 2 hours)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 3(AM + 2 hours)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 3 Mid-day', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 3 Mid-day', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 3(PM)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 3(PM)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 4(AM)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 4(AM)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 4 Mid-day', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 4 Mid-day', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 4(PM)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 4(PM)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 5(AM)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 5(AM)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 5 Mid-day', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 5 Mid-day', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 5(PM)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 5(PM)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 6(AM)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 6(AM)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 6 Mid-day', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 6 Mid-day', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 6(PM)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 6(PM)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 7(AM)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 7(AM)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 7 Mid-day', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 7 Mid-day', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Change at: At Rest Day 7(PM)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Upon Weight Bearing Day 7(PM)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.771', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.51', 'groupDescription': 'At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.07', 'groupDescription': 'At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.05', 'groupDescription': 'At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.720', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.55', 'groupDescription': 'Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.194', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.15', 'groupDescription': 'Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.163', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.15', 'groupDescription': 'Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.644', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.64', 'groupDescription': 'At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.129', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.11', 'groupDescription': 'At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '0.09', 'groupDescription': 'At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.905', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.57', 'groupDescription': 'Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.279', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.22', 'groupDescription': 'Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.29', 'groupDescription': 'Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.203', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.91', 'groupDescription': 'At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.207', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.18', 'groupDescription': 'At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '-0.07', 'groupDescription': 'At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.372', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.84', 'groupDescription': 'Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.532', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.36', 'groupDescription': 'Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.189', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.21', 'groupDescription': 'Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.264', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.87', 'groupDescription': 'At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.260', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.22', 'groupDescription': 'At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.01', 'groupDescription': 'At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.456', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.81', 'groupDescription': 'Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.639', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.68', 'groupDescription': 'Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.780', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.57', 'groupDescription': 'Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.071', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '1.07', 'groupDescription': 'At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.468', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.32', 'groupDescription': 'At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.08', 'groupDescription': 'At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '1.09', 'groupDescription': 'Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.947', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.53', 'groupDescription': 'Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.16', 'groupDescription': 'Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.12', 'ciUpperLimit': '1.23', 'groupDescription': 'At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.715', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.41', 'groupDescription': 'At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '-0.15', 'groupDescription': 'At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.07', 'ciUpperLimit': '1.23', 'groupDescription': 'Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.660', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.65', 'groupDescription': 'Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.11', 'groupDescription': 'Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.10', 'ciUpperLimit': '1.13', 'groupDescription': 'At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.749', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.40', 'groupDescription': 'At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.12', 'groupDescription': 'At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.96', 'groupDescription': 'Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.727', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.61', 'groupDescription': 'Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.336', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.32', 'groupDescription': 'Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.87', 'groupDescription': 'At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.277', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.21', 'groupDescription': 'At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.04', 'groupDescription': 'At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.858', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.60', 'groupDescription': 'Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.724', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.42', 'groupDescription': 'Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.651', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.48', 'groupDescription': 'Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '1.05', 'groupDescription': 'At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.766', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.42', 'groupDescription': 'At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '0.01', 'groupDescription': 'At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.92', 'groupDescription': 'Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.911', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.55', 'groupDescription': 'Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '0.30', 'groupDescription': 'Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.075', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '1.02', 'groupDescription': 'At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.684', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.60', 'groupDescription': 'At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.208', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.21', 'groupDescription': 'At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.304', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.85', 'groupDescription': 'Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.356', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.76', 'groupDescription': 'Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.58', 'groupDescription': 'Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.10', 'ciUpperLimit': '1.15', 'groupDescription': 'At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.940', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.47', 'groupDescription': 'At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '-0.06', 'groupDescription': 'At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.206', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.95', 'groupDescription': 'Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.310', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.81', 'groupDescription': 'Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.771', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.55', 'groupDescription': 'Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.24', 'groupDescription': 'At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.905', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.54', 'groupDescription': 'At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '-0.03', 'groupDescription': 'At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.276', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.93', 'groupDescription': 'Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.343', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.82', 'groupDescription': 'Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.60', 'groupDescription': 'Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.19', 'ciUpperLimit': '1.29', 'groupDescription': 'At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.763', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.43', 'groupDescription': 'At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '-0.20', 'groupDescription': 'At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.09', 'groupDescription': 'Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.533', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.73', 'groupDescription': 'Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '0.35', 'groupDescription': 'Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.23', 'groupDescription': 'At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.483', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.33', 'groupDescription': 'At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.25', 'groupDescription': 'At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.177', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '1.00', 'groupDescription': 'Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.586', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.70', 'groupDescription': 'Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.448', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.41', 'groupDescription': 'Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.09', 'groupDescription': 'At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.688', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.39', 'groupDescription': 'At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.06', 'groupDescription': 'At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.99', 'groupDescription': 'Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.609', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.69', 'groupDescription': 'Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.435', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.40', 'groupDescription': 'Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.10', 'ciUpperLimit': '1.26', 'groupDescription': 'At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.987', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.53', 'groupDescription': 'At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.03', 'groupDescription': 'At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.319', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.94', 'groupDescription': 'Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.712', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.69', 'groupDescription': 'Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.557', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.49', 'groupDescription': 'Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.28', 'groupDescription': 'At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.326', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.79', 'groupDescription': 'At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.19', 'groupDescription': 'At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.350', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.93', 'groupDescription': 'Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.235', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.93', 'groupDescription': 'Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.76', 'groupDescription': 'Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.16', 'groupDescription': 'At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.656', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.63', 'groupDescription': 'At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.14', 'groupDescription': 'At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.304', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.95', 'groupDescription': 'Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.491', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.78', 'groupDescription': 'Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.726', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.57', 'groupDescription': 'Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.07', 'ciUpperLimit': '1.23', 'groupDescription': 'At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.585', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.68', 'groupDescription': 'At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.15', 'groupDescription': 'At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.215', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '1.04', 'groupDescription': 'Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.244', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.94', 'groupDescription': 'Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.885', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.66', 'groupDescription': 'Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '1.13', 'groupDescription': 'At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.500', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.73', 'groupDescription': 'At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.276', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '0.29', 'groupDescription': 'At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.413', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.92', 'groupDescription': 'Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.448', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.83', 'groupDescription': 'Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.917', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.69', 'groupDescription': 'Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.132', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '1.03', 'groupDescription': 'At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.505', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.72', 'groupDescription': 'At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.38', 'groupDescription': 'At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.747', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.76', 'groupDescription': 'Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.386', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.87', 'groupDescription': 'Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.668', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.89', 'groupDescription': 'Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.099', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '1.08', 'groupDescription': 'At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.365', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.79', 'groupDescription': 'At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.463', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.41', 'groupDescription': 'At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.845', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.73', 'groupDescription': 'Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.199', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '1.02', 'groupDescription': 'Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '1.08', 'groupDescription': 'Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.07', 'ciUpperLimit': '1.27', 'groupDescription': 'At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.188', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.92', 'groupDescription': 'At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '0.37', 'groupDescription': 'At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.552', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.89', 'groupDescription': 'Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.126', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '1.12', 'groupDescription': 'Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.460', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '1.05', 'groupDescription': 'Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.095', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '1.09', 'groupDescription': 'At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.146', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.94', 'groupDescription': 'At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.56', 'groupDescription': 'At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.405', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.96', 'groupDescription': 'Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.073', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '1.20', 'groupDescription': 'Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '1.04', 'groupDescription': 'Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.39', 'groupDescription': 'At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.209', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.90', 'groupDescription': 'At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.22', 'groupDescription': 'At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.149', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '1.18', 'groupDescription': 'Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.186', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '1.06', 'groupDescription': 'Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.69', 'groupDescription': 'Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '1.14', 'groupDescription': 'At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.242', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.87', 'groupDescription': 'At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.43', 'groupDescription': 'At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.330', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '1.02', 'groupDescription': 'Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.124', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '1.13', 'groupDescription': 'Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.92', 'groupDescription': 'Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1', 'description': 'PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'At Rest over 6 Hours on Day 1', 'categories': [{'measurements': [{'value': '10.4', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Weight Bearing over 6 Hours on Day 1', 'categories': [{'measurements': [{'value': '11.7', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'At Rest over 2 Hours on Day 3', 'categories': [{'measurements': [{'value': '109.6', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '8.80', 'groupId': 'OG001'}, {'value': '84.7', 'spread': '6.60', 'groupId': 'OG002'}]}]}, {'title': 'Weight Bearing over 2 Hours on Day 3', 'categories': [{'measurements': [{'value': '116.1', 'spread': '10.11', 'groupId': 'OG000'}, {'value': '106.8', 'spread': '9.29', 'groupId': 'OG001'}, {'value': '102.4', 'spread': '7.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.166', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '4.95', 'groupDescription': 'At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.199', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-4.42', 'ciUpperLimit': '0.93', 'groupDescription': 'At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-7.04', 'ciUpperLimit': '-0.56', 'groupDescription': 'At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.260', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '4.79', 'groupDescription': 'Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.729', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-3.31', 'ciUpperLimit': '2.32', 'groupDescription': 'Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-5.64', 'ciUpperLimit': '1.16', 'groupDescription': 'Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.9', 'ciLowerLimit': '2.49', 'ciUpperLimit': '47.28', 'groupDescription': 'At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.2', 'ciLowerLimit': '-55.24', 'ciUpperLimit': '-5.23', 'groupDescription': 'At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-25.98', 'ciUpperLimit': '15.29', 'groupDescription': 'At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.251', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '-9.80', 'ciUpperLimit': '37.36', 'groupDescription': 'Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.689', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-17.37', 'ciUpperLimit': '26.26', 'groupDescription': 'Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.486', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.3', 'ciLowerLimit': '-35.69', 'ciUpperLimit': '17.01', 'groupDescription': 'Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 6 hours on Day 1, over 2 hours on Day 3', 'description': 'PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Difference Scores at Rest Over 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '177.6', 'spread': '13.90', 'groupId': 'OG000'}, {'value': '131.1', 'spread': '12.83', 'groupId': 'OG001'}, {'value': '139.0', 'spread': '9.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.5', 'ciLowerLimit': '5.90', 'ciUpperLimit': '71.18', 'groupDescription': 'At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.603', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-38.02', 'ciUpperLimit': '22.12', 'groupDescription': 'At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.5', 'ciLowerLimit': '-82.93', 'ciUpperLimit': '-10.05', 'groupDescription': 'At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 3 Days (0-72 hours)', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'At Rest: Over 7 Days', 'categories': [{'measurements': [{'value': '472.5', 'spread': '31.60', 'groupId': 'OG000'}, {'value': '396.6', 'spread': '29.16', 'groupId': 'OG001'}, {'value': '384.8', 'spread': '21.88', 'groupId': 'OG002'}]}]}, {'title': 'Weight Bearing: Over 7 Days', 'categories': [{'measurements': [{'value': '516.4', 'spread': '34.52', 'groupId': 'OG000'}, {'value': '507.7', 'spread': '31.70', 'groupId': 'OG001'}, {'value': '470.4', 'spread': '24.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.7', 'ciLowerLimit': '13.48', 'ciUpperLimit': '161.85', 'groupDescription': 'At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.735', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.8', 'ciLowerLimit': '-56.59', 'ciUpperLimit': '80.11', 'groupDescription': 'At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-75.9', 'ciLowerLimit': '-158.73', 'ciUpperLimit': '6.93', 'groupDescription': 'At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.261', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.0', 'ciLowerLimit': '-34.43', 'ciUpperLimit': '126.52', 'groupDescription': 'Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.325', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.3', 'ciLowerLimit': '-37.13', 'ciUpperLimit': '111.80', 'groupDescription': 'Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.7', 'ciLowerLimit': '-98.64', 'ciUpperLimit': '81.22', 'groupDescription': 'Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 7 days (0-168 hours)', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'Change at: Day 3', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Change at: Day 10', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.49', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.114', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.40', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.20', 'groupDescription': 'Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.833', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.19', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.853', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.22', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \\< 0 for Ibuprofen treatment significantly better than combined Placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.29', 'groupDescription': 'Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 3, 10', 'description': "Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': "Participant's Global Assessment of Medication at End of Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '4', 'spread': '1.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10', 'description': 'Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure."}, {'type': 'SECONDARY', 'title': 'Time to First Perceptible Relief and Meaningful Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'title': 'First Perceptible Relief', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '15.7'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '56.4'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '15.7', 'upperLimit': '30.3'}]}]}, {'title': 'Meaningful Relief', 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '67.5'}, {'value': 'NA', 'comment': 'Median and Confidence interval (CI) was not analyzed, as median was greater than 180 minutes.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '72.6', 'groupId': 'OG002', 'lowerLimit': '58.1', 'upperLimit': '116.1'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.97', 'groupDescription': 'Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.', 'statisticalMethod': 'Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.95', 'groupDescription': 'Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.', 'statisticalMethod': 'Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.69', 'groupDescription': 'Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.', 'statisticalMethod': 'Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.27', 'ciUpperLimit': '2.51', 'groupDescription': 'Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.', 'statisticalMethod': 'Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.88', 'groupDescription': 'Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.', 'statisticalMethod': 'Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.52', 'groupDescription': 'Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.', 'statisticalMethod': 'Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value \\<=0.05 for treatment effects', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 3 hours on Day 1', 'description': 'Participants evaluated time to first perceptible relief by stopping a stopwatch labelled \'first perceptible relief\' at moment participant first began to experience any relief, exact question asked was: "Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief". First perceptible relief was considered confirmed by meaningful relief if participant achieved both "first perceptible" and "meaningful" relief by either pressing second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". For "time to meaningful relief," exact question asked was: "Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you." Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'timeFrame': 'Post-Dose on Day 1 up to Day 10', 'description': 'Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed since \\<20% participants used rescue medication.'}, {'type': 'SECONDARY', 'title': 'Number of Doses of Rescue Medication Used During the First 7 Days of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '3.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.479', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.', 'testedNonInferiority': False}, {'pValue': '0.279', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.', 'testedNonInferiority': False}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Day 7', 'description': 'Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.', 'unitOfMeasure': 'Doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Taking Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'OG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '25.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post first dose Day 1 up to Day 10', 'description': 'Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'FG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'FG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Medication Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study was conducted in United States from 08 November 2013 to 19 February 2015.', 'preAssignmentDetails': 'Out of the 348 screened participants, 304 were randomized and received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '304', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibuprofen Twice Daily', 'description': 'Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'BG001', 'title': 'Ibuprofen Thrice Daily', 'description': 'Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.'}, {'id': 'BG002', 'title': 'Placebo Combined', 'description': 'Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '15.20', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '14.72', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '13.90', 'groupId': 'BG002'}, {'value': '33.3', 'spread': '14.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Categorical Pain Severity Rating (PSR)', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '43', 'spread': '1.25', 'groupId': 'BG000'}, {'value': '63', 'spread': '1.13', 'groupId': 'BG001'}, {'value': '102', 'spread': '1.17', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were assessed by 4-Point category pain severity rating scale. Participants rated their pain upon weight bearing using a four-point scale, as follows: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. All participants had moderate or severe ankle pain upon weight bearing at baseline.', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Ankle Pain upon Weight Bearing', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '1.25', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '1.13', 'groupId': 'BG001'}, {'value': '8.4', 'spread': '1.17', 'groupId': 'BG002'}, {'value': '8.3', 'spread': '1.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Participants rated their pain on full weight-bearing movement. Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain and this best describes their current pain in the injured ankle. At baseline, participants recorded a value of at least 6 (inclusive) to be eligible to participate in the study.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Ankle Pain at Rest', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.77', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '1.48', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '1.70', 'groupId': 'BG002'}, {'value': '6.4', 'spread': '1.65', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Participants rated their pain at rest. PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain and this best describes their current pain in the injured ankle.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Baseline Participant's Global Assessment of Ankle Injury", 'classes': [{'title': 'Very Good(1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Good(2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Fair(3)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Poor(4)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}]}, {'title': 'Very Poor(5)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were asked the following question: "Considering all the ways your ankle injury affects you, how are you doing today?" The participant\'s response was recorded using a 5-point scale: 1 = Very Good, No symptoms and no limitations of normal activities; 2 = Good, Mild symptoms and no limitation of normal activities; 3 = Fair, Moderate symptoms and limitations of some normal activities; 4 = Poor, Severe symptoms and inability to carry out most normal activities; and 5 = Very Poor, Very severe symptoms which are intolerable and inability to carry out all normal activities.', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Physician Global Assessment of Ankle Injury', 'classes': [{'title': 'Normal(0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Very mild(1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Mild(2)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Moderate(3)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}]}, {'title': 'Severe(4)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Very severe(5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': "The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and graded using the following 6-point scale: 0 = Normal, No signs or symptoms; 1= Very mild, Very mild signs and symptoms; 2 = Mild, Mild signs and symptoms; 3 = Moderate, Moderate signs and symptoms; 4 = Severe, Severe signs and symptoms; 5 = Very severe, Very severe signs and symptoms.", 'unitOfMeasure': 'participants'}, {'title': 'Baseline Participant Assessment of Normal Function/Activity', 'classes': [{'title': 'Normal walking/activity and no pain(1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Normal walking/activity with pain(2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Mild restrict walking(3)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Moderate restrict walking(4)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}]}, {'title': 'Severe restrict walking(5)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were asked the following question: "How does your ankle injury affect your walking and normal activity?" The participant\'s response was recorded using a 5-point scale: 1=Normal activity and no pain; 2=Normal activity with pain; 3=Mildly restricted walking due to pain and can\'t resume normal activities; 4=Moderately restricted walking due to pain and can\'t resume normal activities; 5=Severely restricted walking due to pain and can\'t resume normal activities. The score ranges from 1-5, with higher scores indicates restricted activity.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2013-06-21', 'resultsFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-19', 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)', 'timeFrame': 'Over 3 Days (0-72 hours)', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.'}, {'measure': 'Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)', 'timeFrame': '0 to 24 hours', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.'}], 'secondaryOutcomes': [{'measure': 'Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)', 'timeFrame': '0 to 24 hours', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.'}, {'measure': "Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10", 'timeFrame': 'Baseline, Day 3, 10', 'description': "Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities)."}, {'measure': 'Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10', 'timeFrame': 'Baseline, Day 3, 10', 'description': "The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value."}, {'measure': 'Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points', 'timeFrame': 'Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1', 'description': 'PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.'}, {'measure': 'Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3', 'timeFrame': 'Over 6 hours on Day 1, over 2 hours on Day 3', 'description': 'PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.'}, {'measure': 'Sum of Pain Intensity Difference Scores at Rest Over 3 Days', 'timeFrame': 'Over 3 Days (0-72 hours)', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.'}, {'measure': 'Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days', 'timeFrame': 'Over 7 days (0-168 hours)', 'description': 'PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.'}, {'measure': 'Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10', 'timeFrame': 'Baseline, Day 3, 10', 'description': "Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity."}, {'measure': "Participant's Global Assessment of Medication at End of Study", 'timeFrame': 'Day 10', 'description': 'Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.'}, {'measure': 'Time to First Perceptible Relief and Meaningful Relief', 'timeFrame': '0 to 3 hours on Day 1', 'description': 'Participants evaluated time to first perceptible relief by stopping a stopwatch labelled \'first perceptible relief\' at moment participant first began to experience any relief, exact question asked was: "Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief". First perceptible relief was considered confirmed by meaningful relief if participant achieved both "first perceptible" and "meaningful" relief by either pressing second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". For "time to meaningful relief," exact question asked was: "Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you." Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered.'}, {'measure': 'Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose', 'timeFrame': 'Post-Dose on Day 1 up to Day 10', 'description': 'Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.'}, {'measure': 'Number of Doses of Rescue Medication Used During the First 7 Days of Dosing', 'timeFrame': 'Baseline up to Day 7', 'description': 'Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.'}, {'measure': 'Percentage of Participants Taking Rescue Medication', 'timeFrame': 'Post first dose Day 1 up to Day 10', 'description': 'Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['topical ibuprofen', 'ankle sprain'], 'conditions': ['Ankle Injuries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3491009&StudyName=5%25%20Topical%20Ibuprofen%20%28IBU%29%20for%20Ankle%20Sprain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First or second degree ankle sprain within 48 hours of first dose of study medication\n* Medically cleared to participate\n\nExclusion Criteria:\n\n* Similar injury of same joint within last 6 months\n* Requires bed rest, surgery, or over-the-counter or prescription analgesics'}, 'identificationModule': {'nctId': 'NCT01945034', 'briefTitle': '5% Topical Ibuprofen (IBU) for Ankle Sprain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain', 'orgStudyIdInfo': {'id': 'B3491009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical IBU twice daily', 'interventionNames': ['Drug: Topical IBU twice daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo twice daily', 'interventionNames': ['Drug: Placebo twice daily']}, {'type': 'EXPERIMENTAL', 'label': 'Topical IBU three times daily', 'interventionNames': ['Drug: Topical IBU three times daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo three times daily', 'interventionNames': ['Drug: Placebo three times daily']}], 'interventions': [{'name': 'Topical IBU twice daily', 'type': 'DRUG', 'description': 'Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days', 'armGroupLabels': ['Topical IBU twice daily']}, {'name': 'Placebo twice daily', 'type': 'DRUG', 'description': 'Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days', 'armGroupLabels': ['Placebo twice daily']}, {'name': 'Topical IBU three times daily', 'type': 'DRUG', 'description': 'Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days', 'armGroupLabels': ['Topical IBU three times daily']}, {'name': 'Placebo three times daily', 'type': 'DRUG', 'description': 'Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days', 'armGroupLabels': ['Placebo three times daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Helen Keller Hospital', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'eStudy Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Sports Medicine and Family Health Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33130', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Research Institute, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'L&L Research Choices', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Doctors Research Network', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Elite Clinical Trials LLLP', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MedPharmics, LLC', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Quality Clinical Research, Inc.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Heartland Clinical Research, Inc.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Salisbury', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Lillestol Research, LLC', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trial Network', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sports Medicine Associates of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Danville Orthopedic Clinic', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}