Viewing Study NCT05485805

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 3:18 AM

Ignite Modification Date: 2025-12-26 @ 1:56 AM

Study NCT ID: NCT05485805

Status: COMPLETED

Last Update Posted: 2025-03-25

First Post: 2022-07-28

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Bayer Clinical Trials Contact', 'organization': 'Bayer AG'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 19, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 11, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 4, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 3, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 23, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alveolar osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.293', 'spread': '1.441', 'groupId': 'OG000', 'lowerLimit': '1.441'}, {'value': '37.242', 'spread': '1.436', 'groupId': 'OG001', 'lowerLimit': '1.436'}, {'value': '31.082', 'spread': '1.443', 'groupId': 'OG002', 'lowerLimit': '1.443'}, {'value': '5.146', 'spread': '2.470', 'groupId': 'OG003', 'lowerLimit': '2.470'}, {'value': '8.622', 'spread': '2.521', 'groupId': 'OG004', 'lowerLimit': '2.521'}]}]}], 'analyses': [{'pValue': '= 0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.95', 'ciLowerLimit': '-9.946', 'ciUpperLimit': '-1.954', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.161', 'ciLowerLimit': '2.161', 'ciUpperLimit': '10.161', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.936', 'ciLowerLimit': '20.317', 'ciUpperLimit': '31.556', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.325', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.476', 'ciLowerLimit': '-10.41', 'ciUpperLimit': '3.457', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.918', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.211', 'ciLowerLimit': '-3.798', 'ciUpperLimit': '4.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.097', 'ciLowerLimit': '26.484', 'ciUpperLimit': '37.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.46', 'ciLowerLimit': '16.753', 'ciUpperLimit': '28.166', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.147', 'ciLowerLimit': '20.529', 'ciUpperLimit': '31.765', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.62', 'ciLowerLimit': '22.921', 'ciUpperLimit': '34.32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.671', 'ciLowerLimit': '16.966', 'ciUpperLimit': '28.375', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 8 hours post-dose', 'description': 'Pain intensity scale is the Numerical Rating Scale measured from 0 to 10, where 0 indicates no pain and 10 means the wors pain imaginable.\n\nPain intensity Difference (PID) is calculated by subtracting the pain intensity at different time points in the post-dose time point from the pain intensity at baseline.\n\nThe summed pain intensity difference (SPID) is to be calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then summing the values over the relevant time period. For SPID (0-8), eight PIDs are summed up, which is minimally 0, if there is no pain relief or maximally 80, if there is very strong pain and significant pain relief.', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': '0-2 hours post-dose', 'categories': [{'measurements': [{'value': '7.347', 'spread': '0.341', 'groupId': 'OG000', 'lowerLimit': '0.341'}, {'value': '8.950', 'spread': '0.340', 'groupId': 'OG001', 'lowerLimit': '0.340'}, {'value': '7.973', 'spread': '0.341', 'groupId': 'OG002', 'lowerLimit': '0.341'}, {'value': '1.876', 'spread': '0.585', 'groupId': 'OG003', 'lowerLimit': '0.585'}, {'value': '1.567', 'spread': '0.597', 'groupId': 'OG004', 'lowerLimit': '0.597'}]}]}, {'title': '0-4 hours post-dose', 'categories': [{'measurements': [{'value': '15.899', 'spread': '0.688', 'groupId': 'OG000', 'lowerLimit': '0.688'}, {'value': '19.210', 'spread': '0.686', 'groupId': 'OG001', 'lowerLimit': '0.686'}, {'value': '16.627', 'spread': '0.689', 'groupId': 'OG002', 'lowerLimit': '0.689'}, {'value': '2.924', 'spread': '1.179', 'groupId': 'OG003', 'lowerLimit': '1.179'}, {'value': '3.982', 'spread': '1.204', 'groupId': 'OG004', 'lowerLimit': '1.204'}]}]}, {'title': '0-6 hours post-dose', 'categories': [{'measurements': [{'value': '23.851', 'spread': '1.057', 'groupId': 'OG000', 'lowerLimit': '1.057'}, {'value': '28.632', 'spread': '1.053', 'groupId': 'OG001', 'lowerLimit': '1.053'}, {'value': '24.381', 'spread': '1.058', 'groupId': 'OG002', 'lowerLimit': '1.058'}, {'value': '4.024', 'spread': '1.812', 'groupId': 'OG003', 'lowerLimit': '1.812'}, {'value': '6.308', 'spread': '1.849', 'groupId': 'OG004', 'lowerLimit': '1.849'}]}]}, {'title': '0-12 hours post-dose', 'categories': [{'measurements': [{'value': '44.207', 'spread': '2.266', 'groupId': 'OG000', 'lowerLimit': '2.266'}, {'value': '51.737', 'spread': '2.258', 'groupId': 'OG001', 'lowerLimit': '2.258'}, {'value': '42.907', 'spread': '2.268', 'groupId': 'OG002', 'lowerLimit': '2.268'}, {'value': '7.003', 'spread': '3.883', 'groupId': 'OG003', 'lowerLimit': '3.883'}, {'value': '13.455', 'spread': '3.964', 'groupId': 'OG004', 'lowerLimit': '3.964'}]}]}, {'title': '0-24 hours post-dose', 'categories': [{'measurements': [{'value': '77.596', 'spread': '4.949', 'groupId': 'OG000', 'lowerLimit': '4.949'}, {'value': '83.884', 'spread': '4.930', 'groupId': 'OG001', 'lowerLimit': '4.930'}, {'value': '72.796', 'spread': '4.953', 'groupId': 'OG002', 'lowerLimit': '4.953'}, {'value': '12.533', 'spread': '8.481', 'groupId': 'OG003', 'lowerLimit': '8.481'}, {'value': '28.400', 'spread': '8.656', 'groupId': 'OG004', 'lowerLimit': '8.656'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.602', 'ciLowerLimit': '-2.548', 'ciUpperLimit': '-0.656', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.043', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.976', 'ciLowerLimit': '0.029', 'ciUpperLimit': '1.923', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.097', 'ciLowerLimit': '4.766', 'ciUpperLimit': '7.427', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.711', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-1.332', 'ciUpperLimit': '1.951', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.196', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.626', 'ciLowerLimit': '-1.575', 'ciUpperLimit': '0.323', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.073', 'ciLowerLimit': '5.744', 'ciUpperLimit': '8.402', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.406', 'ciLowerLimit': '5.055', 'ciUpperLimit': '7.757', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.471', 'ciLowerLimit': '4.141', 'ciUpperLimit': '6.801', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.383', 'ciLowerLimit': '6.033', 'ciUpperLimit': '8.732', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.78', 'ciLowerLimit': '4.43', 'ciUpperLimit': '7.131', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from 0 to 2, 4, 6, 12 and 24 hours post-dose', 'description': 'Pain intensity scale is the Numerical Rating Scale measured from 0 to 10, where 0 indicates no pain and 10 means the wors pain imaginable.\n\nPain intensity Difference (PID) is calculated by subtracting the pain intensity at different time points in the post-dose time point from the pain intensity at baseline.\n\nThe summed pain intensity difference (SPID) is to be calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then summing the values over the relevant time period. For SPID(0-i), i PIDs are summed up, which minimally is 0, if there is no pain relief or maximally i\\*10, if there is very strong pain and significant pain relief.', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': '0-2 hours post-dose', 'categories': [{'measurements': [{'value': '3.284', 'spread': '0.114', 'groupId': 'OG000', 'lowerLimit': '0.114'}, {'value': '3.870', 'spread': '0.114', 'groupId': 'OG001', 'lowerLimit': '0.114'}, {'value': '3.417', 'spread': '0.115', 'groupId': 'OG002', 'lowerLimit': '0.115'}, {'value': '1.047', 'spread': '0.196', 'groupId': 'OG003', 'lowerLimit': '0.196'}, {'value': '1.216', 'spread': '0.200', 'groupId': 'OG004', 'lowerLimit': '0.200'}]}]}, {'title': '0-4 hours post-dose', 'categories': [{'measurements': [{'value': '7.781', 'spread': '0.287', 'groupId': 'OG000', 'lowerLimit': '0.287'}, {'value': '9.118', 'spread': '0.286', 'groupId': 'OG001', 'lowerLimit': '0.286'}, {'value': '8.102', 'spread': '0.287', 'groupId': 'OG002', 'lowerLimit': '0.287'}, {'value': '2.120', 'spread': '0.492', 'groupId': 'OG003', 'lowerLimit': '0.492'}, {'value': '3.168', 'spread': '0.502', 'groupId': 'OG004', 'lowerLimit': '0.502'}]}]}, {'title': '0-6 hours post-dose', 'categories': [{'measurements': [{'value': '12.098', 'spread': '0.465', 'groupId': 'OG000', 'lowerLimit': '0.465'}, {'value': '14.061', 'spread': '0.464', 'groupId': 'OG001', 'lowerLimit': '0.464'}, {'value': '12.420', 'spread': '0.466', 'groupId': 'OG002', 'lowerLimit': '0.466'}, {'value': '3.228', 'spread': '0.798', 'groupId': 'OG003', 'lowerLimit': '0.798'}, {'value': '4.870', 'spread': '0.814', 'groupId': 'OG004', 'lowerLimit': '0.814'}]}]}, {'title': '0-8 hours post-dose', 'categories': [{'measurements': [{'value': '16.227', 'spread': '0.645', 'groupId': 'OG000', 'lowerLimit': '0.645'}, {'value': '18.625', 'spread': '0.642', 'groupId': 'OG001', 'lowerLimit': '0.642'}, {'value': '16.225', 'spread': '0.645', 'groupId': 'OG002', 'lowerLimit': '0.645'}, {'value': '4.327', 'spread': '1.105', 'groupId': 'OG003', 'lowerLimit': '1.105'}, {'value': '6.552', 'spread': '1.128', 'groupId': 'OG004', 'lowerLimit': '1.128'}]}]}, {'title': '0-12 hours post-dose', 'categories': [{'measurements': [{'value': '23.512', 'spread': '1.029', 'groupId': 'OG000', 'lowerLimit': '1.029'}, {'value': '26.461', 'spread': '1.026', 'groupId': 'OG001', 'lowerLimit': '1.026'}, {'value': '22.767', 'spread': '1.030', 'groupId': 'OG002', 'lowerLimit': '1.030'}, {'value': '6.264', 'spread': '1.764', 'groupId': 'OG003', 'lowerLimit': '1.764'}, {'value': '9.700', 'spread': '1.801', 'groupId': 'OG004', 'lowerLimit': '1.801'}]}]}, {'title': '0-24 hours post-dose', 'categories': [{'measurements': [{'value': '41.596', 'spread': '2.281', 'groupId': 'OG000', 'lowerLimit': '2.281'}, {'value': '43.908', 'spread': '2.272', 'groupId': 'OG001', 'lowerLimit': '2.272'}, {'value': '39.127', 'spread': '2.283', 'groupId': 'OG002', 'lowerLimit': '2.283'}, {'value': '12.047', 'spread': '3.909', 'groupId': 'OG003', 'lowerLimit': '3.909'}, {'value': '18.975', 'spread': '3.990', 'groupId': 'OG004', 'lowerLimit': '3.990'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.586', 'ciLowerLimit': '-0.903', 'ciUpperLimit': '-0.269', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.454', 'ciLowerLimit': '0.136', 'ciUpperLimit': '0.771', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.369', 'ciLowerLimit': '1.923', 'ciUpperLimit': '2.815', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.548', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.169', 'ciLowerLimit': '-0.719', 'ciUpperLimit': '0.382', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.415', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.132', 'ciLowerLimit': '-0.451', 'ciUpperLimit': '0.186', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.823', 'ciLowerLimit': '2.377', 'ciUpperLimit': '3.268', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.201', 'ciLowerLimit': '1.748', 'ciUpperLimit': '2.654', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.237', 'ciLowerLimit': '1.791', 'ciUpperLimit': '2.683', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.654', 'ciLowerLimit': '2.202', 'ciUpperLimit': '3.106', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.068', 'ciLowerLimit': '1.615', 'ciUpperLimit': '2.521', 'groupDescription': '0-2 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.338', 'ciLowerLimit': '-2.133', 'ciUpperLimit': '-0.542', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.012', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.016', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.813', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.982', 'ciLowerLimit': '4.864', 'ciUpperLimit': '7.101', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.136', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.048', 'ciLowerLimit': '-2.428', 'ciUpperLimit': '0.332', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.43', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.321', 'ciLowerLimit': '-1.119', 'ciUpperLimit': '0.477', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.999', 'ciLowerLimit': '5.881', 'ciUpperLimit': '8.116', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.934', 'ciLowerLimit': '3.798', 'ciUpperLimit': '6.07', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.661', 'ciLowerLimit': '4.543', 'ciUpperLimit': '6.779', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.951', 'ciLowerLimit': '4.816', 'ciUpperLimit': '7.085', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.613', 'ciLowerLimit': '3.478', 'ciUpperLimit': '5.749', 'groupDescription': '0-4 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.963', 'ciLowerLimit': '-3.254', 'ciUpperLimit': '-0.673', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.641', 'ciLowerLimit': '0.35', 'ciUpperLimit': '2.933', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.191', 'ciLowerLimit': '7.377', 'ciUpperLimit': '11.006', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.15', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.642', 'ciLowerLimit': '-3.881', 'ciUpperLimit': '0.597', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.625', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.322', 'ciLowerLimit': '-1.617', 'ciUpperLimit': '0.972', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.833', 'ciLowerLimit': '9.02', 'ciUpperLimit': '12.645', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.55', 'ciLowerLimit': '5.707', 'ciUpperLimit': '9.392', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.869', 'ciLowerLimit': '7.055', 'ciUpperLimit': '10.683', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.191', 'ciLowerLimit': '7.351', 'ciUpperLimit': '11.031', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.228', 'ciLowerLimit': '5.386', 'ciUpperLimit': '9.07', 'groupDescription': '0-6 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.398', 'ciLowerLimit': '-4.185', 'ciUpperLimit': '-0.61', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '0.61', 'ciUpperLimit': '4.189', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.898', 'ciLowerLimit': '9.384', 'ciUpperLimit': '14.412', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.159', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.225', 'ciLowerLimit': '-5.327', 'ciUpperLimit': '0.877', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.998', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.002', 'ciLowerLimit': '-1.792', 'ciUpperLimit': '1.795', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.298', 'ciLowerLimit': '11.787', 'ciUpperLimit': '16.809', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.673', 'ciLowerLimit': '7.12', 'ciUpperLimit': '12.226', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '9.387', 'ciUpperLimit': '14.413', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.073', 'ciLowerLimit': '9.523', 'ciUpperLimit': '14.623', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.675', 'ciLowerLimit': '7.123', 'ciUpperLimit': '12.227', 'groupDescription': '0-8 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.949', 'ciLowerLimit': '-5.803', 'ciUpperLimit': '-0.095', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.011', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.694', 'ciLowerLimit': '0.837', 'ciUpperLimit': '6.55', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.504', 'ciLowerLimit': '12.49', 'ciUpperLimit': '20.517', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.173', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.437', 'ciLowerLimit': '-8.389', 'ciUpperLimit': '1.515', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.61', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.744', 'ciLowerLimit': '-2.119', 'ciUpperLimit': '3.608', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.197', 'ciLowerLimit': '16.189', 'ciUpperLimit': '24.206', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.067', 'ciLowerLimit': '8.992', 'ciUpperLimit': '17.143', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.248', 'ciLowerLimit': '13.236', 'ciUpperLimit': '21.261', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.761', 'ciLowerLimit': '12.69', 'ciUpperLimit': '20.831', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.812', 'ciLowerLimit': '9.738', 'ciUpperLimit': '17.886', 'groupDescription': '0-12 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.312', 'ciLowerLimit': '-8.635', 'ciUpperLimit': '4.011', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.08', 'ciLowerLimit': '18.188', 'ciUpperLimit': '35.973', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.215', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.928', 'ciLowerLimit': '-17.9', 'ciUpperLimit': '4.044', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.445', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.468', 'ciLowerLimit': '-3.876', 'ciUpperLimit': '8.813', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.152', 'ciLowerLimit': '11.122', 'ciUpperLimit': '29.183', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.933', 'ciLowerLimit': '15.914', 'ciUpperLimit': '33.952', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.621', 'ciLowerLimit': '13.594', 'ciUpperLimit': '31.648', 'groupDescription': '0-24 hours post-dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Total Pain Relief (TOTPAR) is a cumulative measure that evaluates the overall pain relief over a specific time frame from 0-2,0-4,0-6,0-8,0-12 and 0-24 following drug administration. It is calculated by multiplying the pain relief score from the categorical pain relief scale at each time post-dose time by multiplying the duration (in hours) since the preceding time point and then adding these values. Categorical Pain Relief Scale measure the degree of pain relief using a scale from 0 to 4, in which 0 is no relief, 1 a little relief, 2 some relief, 3 a lot of relief and 4 complete relief. Higher values of TOTPAR indicates better pain relief and suggest that the investigational product provided consistence and meaningful pain relief over the period. Low TOTPAR values indicates minimal pain relief or short-lasting efficacy.', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '17.33', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '14.08', 'upperLimit': 'NA'}, {'value': '19.72', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '11.08', 'upperLimit': 'NA'}, {'value': '2.07', 'groupId': 'OG003', 'lowerLimit': '1.72', 'upperLimit': '2.75'}, {'value': '2.65', 'groupId': 'OG004', 'lowerLimit': '1.67', 'upperLimit': '7.28'}]}]}], 'analyses': [{'pValue': '= 0.963', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.118', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.244', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.139', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': '0.5 hour', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 1 hour', 'categories': [{'measurements': [{'value': '0.007', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.007', 'groupId': 'OG002'}, {'value': '0.04', 'groupId': 'OG003'}, {'value': '0.02', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 1.5 hour', 'categories': [{'measurements': [{'value': '0.027', 'groupId': 'OG000'}, {'value': '0.007', 'groupId': 'OG001'}, {'value': '0.007', 'groupId': 'OG002'}, {'value': '0.3', 'groupId': 'OG003'}, {'value': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 2 hours', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.034', 'groupId': 'OG001'}, {'value': '0.048', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}, {'value': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 3 hours', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}, {'value': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 4hours', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}, {'value': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 5 hours', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}, {'value': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 6 hours', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 7 hours', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 8 hours', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 9 hours', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 10 hours', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 11 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 12 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 14 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 16 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 18 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 20 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 22 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 24 hours', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 hours post-dose', 'unitOfMeasure': 'proportion', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Perceptible Relief Measured by a Stopwatch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '0.42'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.41'}, {'value': '0.35', 'groupId': 'OG002', 'lowerLimit': '0.32', 'upperLimit': '0.39'}, {'value': '0.60', 'groupId': 'OG003', 'lowerLimit': '0.42', 'upperLimit': '4.13'}, {'value': '1.93', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '0.51', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.647', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.714', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.065', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.742', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Meaningful Relief Measured by a Stopwatch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '0.92'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '0.85'}, {'value': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.67', 'upperLimit': '0.93'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '2.24', 'upperLimit': 'NA'}, {'value': '5.63', 'groupId': 'OG004', 'lowerLimit': '2.11', 'upperLimit': '5.78'}]}]}], 'analyses': [{'pValue': '= 0.162', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.319', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.343', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'meaningful relief is the point when the participant perceives their pain as significant and meaningful to them using the double-stopwatched method that allows to differentiate between the onset of the analgesic effect (first perceptible pain relief) and the onset of meaningful pain relief', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Perceptible Relief Confirmed by Meaningful Relief Defined as the Time to Perceptible Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '0.92'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '0.85'}, {'value': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.67', 'upperLimit': '0.93'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '2.24', 'upperLimit': 'NA'}, {'value': '5.63', 'groupId': 'OG004', 'lowerLimit': '2.11', 'upperLimit': '5.78'}]}]}], 'analyses': [{'pValue': '= 0.162', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.319', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.343', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.772', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Difference (PID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.6', 'spread': '1.22', 'groupId': 'OG000', 'lowerLimit': '1.22'}, {'value': '7.6', 'spread': '1.20', 'groupId': 'OG001', 'lowerLimit': '1.20'}, {'value': '7.8', 'spread': '1.21', 'groupId': 'OG002', 'lowerLimit': '1.21'}, {'value': '7.7', 'spread': '1.39', 'groupId': 'OG003', 'lowerLimit': '1.39'}, {'value': '7.7', 'spread': '0.99', 'groupId': 'OG004', 'lowerLimit': '0.99'}]}]}, {'title': '0.5 hours post-dose', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.89', 'groupId': 'OG000', 'lowerLimit': '1.89'}, {'value': '2.3', 'spread': '1.91', 'groupId': 'OG001', 'lowerLimit': '1.91'}, {'value': '2.4', 'spread': '1.98', 'groupId': 'OG002', 'lowerLimit': '1.98'}, {'value': '1.0', 'spread': '1.38', 'groupId': 'OG003', 'lowerLimit': '1.38'}, {'value': '0.6', 'spread': '1.18', 'groupId': 'OG004', 'lowerLimit': '1.18'}]}]}, {'title': '1 hour post-dose', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.40', 'groupId': 'OG000', 'lowerLimit': '2.40'}, {'value': '4.3', 'spread': '2.18', 'groupId': 'OG001', 'lowerLimit': '2.18'}, {'value': '3.7', 'spread': '2.23', 'groupId': 'OG002', 'lowerLimit': '2.23'}, {'value': '0.8', 'spread': '1.67', 'groupId': 'OG003', 'lowerLimit': '1.67'}, {'value': '0.7', 'spread': '1.89', 'groupId': 'OG004', 'lowerLimit': '1.89'}]}]}, {'title': '1.5 hours post-dose', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.40', 'groupId': 'OG000', 'lowerLimit': '2.40'}, {'value': '4.9', 'spread': '2.13', 'groupId': 'OG001', 'lowerLimit': '2.13'}, {'value': '4.3', 'spread': '2.27', 'groupId': 'OG002', 'lowerLimit': '2.27'}, {'value': '0.6', 'spread': '1.68', 'groupId': 'OG003', 'lowerLimit': '1.68'}, {'value': '0.6', 'spread': '2.17', 'groupId': 'OG004', 'lowerLimit': '2.17'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.56', 'groupId': 'OG000', 'lowerLimit': '2.56'}, {'value': '5.2', 'spread': '2.12', 'groupId': 'OG001', 'lowerLimit': '2.12'}, {'value': '4.7', 'spread': '2.30', 'groupId': 'OG002', 'lowerLimit': '2.30'}, {'value': '0.7', 'spread': '1.99', 'groupId': 'OG003', 'lowerLimit': '1.99'}, {'value': '0.9', 'spread': '2.48', 'groupId': 'OG004', 'lowerLimit': '2.48'}]}]}, {'title': '3 hours post-dose', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.55', 'groupId': 'OG000', 'lowerLimit': '2.55'}, {'value': '5.2', 'spread': '2.28', 'groupId': 'OG001', 'lowerLimit': '2.28'}, {'value': '4.4', 'spread': '2.45', 'groupId': 'OG002', 'lowerLimit': '2.45'}, {'value': '0.4', 'spread': '1.94', 'groupId': 'OG003', 'lowerLimit': '1.94'}, {'value': '1.1', 'spread': '2.64', 'groupId': 'OG004', 'lowerLimit': '2.64'}]}]}, {'title': '4 hours post-dose', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.54'}, {'value': '5.1', 'spread': '2.47', 'groupId': 'OG001', 'lowerLimit': '2.47'}, {'value': '4.3', 'spread': '2.65', 'groupId': 'OG002', 'lowerLimit': '2.65'}, {'value': '0.6', 'spread': '2.19', 'groupId': 'OG003', 'lowerLimit': '2.19'}, {'value': '1.4', 'spread': '2.99', 'groupId': 'OG004', 'lowerLimit': '2.99'}]}]}, {'title': '5 hours post-dose', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.55', 'groupId': 'OG000', 'lowerLimit': '2.55'}, {'value': '4.8', 'spread': '2.46', 'groupId': 'OG001', 'lowerLimit': '2.46'}, {'value': '4.1', 'spread': '2.73', 'groupId': 'OG002', 'lowerLimit': '2.73'}, {'value': '0.5', 'spread': '2.11', 'groupId': 'OG003', 'lowerLimit': '2.11'}, {'value': '1.2', 'spread': '2.84', 'groupId': 'OG004', 'lowerLimit': '2.84'}]}]}, {'title': '6 hours post-dose', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.60', 'groupId': 'OG000', 'lowerLimit': '2.60'}, {'value': '4.6', 'spread': '2.48', 'groupId': 'OG001', 'lowerLimit': '2.48'}, {'value': '3.8', 'spread': '2.74', 'groupId': 'OG002', 'lowerLimit': '2.74'}, {'value': '0.6', 'spread': '2.34', 'groupId': 'OG003', 'lowerLimit': '2.34'}, {'value': '1.2', 'spread': '3.01', 'groupId': 'OG004', 'lowerLimit': '3.01'}]}]}, {'title': '7 hours post-dose', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.61', 'groupId': 'OG000', 'lowerLimit': '2.61'}, {'value': '4.4', 'spread': '2.56', 'groupId': 'OG001', 'lowerLimit': '2.56'}, {'value': '3.5', 'spread': '2.80', 'groupId': 'OG002', 'lowerLimit': '2.80'}, {'value': '0.6', 'spread': '2.30', 'groupId': 'OG003', 'lowerLimit': '2.30'}, {'value': '1.2', 'spread': '2.94', 'groupId': 'OG004', 'lowerLimit': '2.94'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.63', 'groupId': 'OG000', 'lowerLimit': '2.63'}, {'value': '4.1', 'spread': '2.60', 'groupId': 'OG001', 'lowerLimit': '2.60'}, {'value': '3.3', 'spread': '2.88', 'groupId': 'OG002', 'lowerLimit': '2.88'}, {'value': '0.6', 'spread': '2.30', 'groupId': 'OG003', 'lowerLimit': '2.30'}, {'value': '1.2', 'spread': '3.00', 'groupId': 'OG004', 'lowerLimit': '3.00'}]}]}, {'title': '9 hours post dose', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.72', 'groupId': 'OG000', 'lowerLimit': '2.72'}, {'value': '3.9', 'spread': '2.68', 'groupId': 'OG001', 'lowerLimit': '2.68'}, {'value': '3.3', 'spread': '2.96', 'groupId': 'OG002', 'lowerLimit': '2.96'}, {'value': '0.6', 'spread': '2.47', 'groupId': 'OG003', 'lowerLimit': '2.47'}, {'value': '1.3', 'spread': '3.15', 'groupId': 'OG004', 'lowerLimit': '3.15'}]}]}, {'title': '10 hours post-dose', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.78', 'groupId': 'OG000', 'lowerLimit': '2.78'}, {'value': '3.8', 'spread': '2.81', 'groupId': 'OG001', 'lowerLimit': '2.81'}, {'value': '3.1', 'spread': '3.03', 'groupId': 'OG002', 'lowerLimit': '3.03'}, {'value': '0.4', 'spread': '2.25', 'groupId': 'OG003', 'lowerLimit': '2.25'}, {'value': '1.3', 'spread': '3.24', 'groupId': 'OG004', 'lowerLimit': '3.24'}]}]}, {'title': '11 hours post-dose', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.84', 'groupId': 'OG000', 'lowerLimit': '2.84'}, {'value': '3.6', 'spread': '2.86', 'groupId': 'OG001', 'lowerLimit': '2.86'}, {'value': '2.9', 'spread': '3.02', 'groupId': 'OG002', 'lowerLimit': '3.02'}, {'value': '0.4', 'spread': '2.34', 'groupId': 'OG003', 'lowerLimit': '2.34'}, {'value': '1.2', 'spread': '3.23', 'groupId': 'OG004', 'lowerLimit': '3.23'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.90', 'groupId': 'OG000', 'lowerLimit': '2.90'}, {'value': '3.2', 'spread': '2.90', 'groupId': 'OG001', 'lowerLimit': '2.90'}, {'value': '2.8', 'spread': '3.07', 'groupId': 'OG002', 'lowerLimit': '3.07'}, {'value': '0.4', 'spread': '2.29', 'groupId': 'OG003', 'lowerLimit': '2.29'}, {'value': '1.3', 'spread': '3.32', 'groupId': 'OG004', 'lowerLimit': '3.32'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.97', 'groupId': 'OG000', 'lowerLimit': '2.97'}, {'value': '2.9', 'spread': '3.01', 'groupId': 'OG001', 'lowerLimit': '3.01'}, {'value': '2.6', 'spread': '3.04', 'groupId': 'OG002', 'lowerLimit': '3.04'}, {'value': '0.4', 'spread': '2.20', 'groupId': 'OG003', 'lowerLimit': '2.20'}, {'value': '1.3', 'spread': '3.32', 'groupId': 'OG004', 'lowerLimit': '3.32'}]}]}, {'title': '16 hours post-dose', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.99'}, {'value': '2.7', 'spread': '2.85', 'groupId': 'OG001', 'lowerLimit': '2.85'}, {'value': '2.4', 'spread': '3.04', 'groupId': 'OG002', 'lowerLimit': '3.04'}, {'value': '0.4', 'spread': '2.27', 'groupId': 'OG003', 'lowerLimit': '2.27'}, {'value': '1.2', 'spread': '3.21', 'groupId': 'OG004', 'lowerLimit': '3.21'}]}]}, {'title': '18 hours post-dose', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.05', 'groupId': 'OG000', 'lowerLimit': '3.05'}, {'value': '2.6', 'spread': '2.83', 'groupId': 'OG001', 'lowerLimit': '2.83'}, {'value': '2.4', 'spread': '3.02', 'groupId': 'OG002', 'lowerLimit': '3.02'}, {'value': '0.4', 'spread': '2.27', 'groupId': 'OG003', 'lowerLimit': '2.27'}, {'value': '1.2', 'spread': '3.22', 'groupId': 'OG004', 'lowerLimit': '3.22'}]}]}, {'title': '20 hours post-dose', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.07', 'groupId': 'OG000', 'lowerLimit': '3.07'}, {'value': '2.6', 'spread': '2.81', 'groupId': 'OG001', 'lowerLimit': '2.81'}, {'value': '2.5', 'spread': '3.06', 'groupId': 'OG002', 'lowerLimit': '3.06'}, {'value': '0.4', 'spread': '2.33', 'groupId': 'OG003', 'lowerLimit': '2.33'}, {'value': '1.2', 'spread': '3.28', 'groupId': 'OG004', 'lowerLimit': '3.28'}]}]}, {'title': '22 hours post-dose', 'categories': [{'measurements': [{'value': '2.8', 'spread': '3.19', 'groupId': 'OG000', 'lowerLimit': '3.19'}, {'value': '2.7', 'spread': '2.85', 'groupId': 'OG001', 'lowerLimit': '2.85'}, {'value': '2.6', 'spread': '3.14', 'groupId': 'OG002', 'lowerLimit': '3.14'}, {'value': '0.5', 'spread': '2.55', 'groupId': 'OG003', 'lowerLimit': '2.55'}, {'value': '1.4', 'spread': '3.51', 'groupId': 'OG004', 'lowerLimit': '3.51'}]}]}, {'title': '24 hours post-dose', 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.19', 'groupId': 'OG000', 'lowerLimit': '3.19'}, {'value': '2.8', 'spread': '2.92', 'groupId': 'OG001', 'lowerLimit': '2.92'}, {'value': '2.6', 'spread': '3.20', 'groupId': 'OG002', 'lowerLimit': '3.20'}, {'value': '0.6', 'spread': '2.62', 'groupId': 'OG003', 'lowerLimit': '2.62'}, {'value': '1.5', 'spread': '3.63', 'groupId': 'OG004', 'lowerLimit': '3.63'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Pain Intensity Difference (PID) is the change of pain intensity at a specific time point compared to baseline using the Numerical Rating Scale from 0 to 10. Value of 0 score means no pain and 10 score result means the worst possible pain. For each post-dose time point, pain intensity differences will be derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score. Positive PID values indicate pain relief (reduction in pain intensity), while negative or small PID values suggest little or no reduction in pain intensity', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': '0.5 hours post-dose', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.93'}, {'value': '1.5', 'spread': '1.01', 'groupId': 'OG001', 'lowerLimit': '1.01'}, {'value': '1.5', 'spread': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.97'}, {'value': '0.7', 'spread': '0.72', 'groupId': 'OG003', 'lowerLimit': '0.72'}, {'value': '0', 'spread': '0.65', 'groupId': 'OG004', 'lowerLimit': '0.65'}]}]}, {'title': '1 hour post-dose', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.04', 'groupId': 'OG000', 'lowerLimit': '1.04'}, {'value': '2.4', 'spread': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.9'}, {'value': '2.1', 'spread': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.99'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.9'}, {'value': '0.8', 'spread': '0.96', 'groupId': 'OG004', 'lowerLimit': '0.96'}]}]}, {'title': '1.5 hours post-dose', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.07', 'groupId': 'OG000', 'lowerLimit': '1.07'}, {'value': '2.6', 'spread': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.87'}, {'value': '2.3', 'spread': '0.94', 'groupId': 'OG002', 'lowerLimit': '0.94'}, {'value': '0.6', 'spread': '0.88', 'groupId': 'OG003', 'lowerLimit': '0.88'}, {'value': '0.8', 'spread': '1.04', 'groupId': 'OG004', 'lowerLimit': '1.04'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.13', 'groupId': 'OG000', 'lowerLimit': '1.13'}, {'value': '2.7', 'spread': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.93'}, {'value': '2.5', 'spread': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.99'}, {'value': '0.7', 'spread': '0.95', 'groupId': 'OG003', 'lowerLimit': '0.95'}, {'value': '0.9', 'spread': '1.17', 'groupId': 'OG004', 'lowerLimit': '1.17'}]}]}, {'title': '3 hours post-dose', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.19'}, {'value': '2.7', 'spread': '1.06', 'groupId': 'OG001', 'lowerLimit': '1.06'}, {'value': '2.4', 'spread': '1.11', 'groupId': 'OG002', 'lowerLimit': '1.11'}, {'value': '0.5', 'spread': '0.93', 'groupId': 'OG003', 'lowerLimit': '0.93'}, {'value': '1.0', 'spread': '1.25', 'groupId': 'OG004', 'lowerLimit': '1.25'}]}]}, {'title': '4 hours post-dose', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.2'}, {'value': '2.6', 'spread': '1.18', 'groupId': 'OG001', 'lowerLimit': '1.18'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.2'}, {'value': '0.6', 'spread': '0.99', 'groupId': 'OG003', 'lowerLimit': '0.99'}, {'value': '1.0', 'spread': '1.35', 'groupId': 'OG004', 'lowerLimit': '1.35'}]}]}, {'title': '5 hours post-dose', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.24'}, {'value': '2.5', 'spread': '1.13', 'groupId': 'OG001', 'lowerLimit': '1.13'}, {'value': '2.3', 'spread': '1.28', 'groupId': 'OG002', 'lowerLimit': '1.28'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG003', 'lowerLimit': '1.03'}, {'value': '0.8', 'spread': '1.17', 'groupId': 'OG004', 'lowerLimit': '1.17'}]}]}, {'title': '6 hours post-dose', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.26', 'groupId': 'OG000', 'lowerLimit': '1.26'}, {'value': '2.5', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '1.12'}, {'value': '2.1', 'spread': '1.28', 'groupId': 'OG002', 'lowerLimit': '1.28'}, {'value': '0.6', 'spread': '1.07', 'groupId': 'OG003', 'lowerLimit': '1.07'}, {'value': '0.9', 'spread': '1.3', 'groupId': 'OG004', 'lowerLimit': '1.3'}]}]}, {'title': '7 hours post-dose', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.27', 'groupId': 'OG000', 'lowerLimit': '1.27'}, {'value': '2.3', 'spread': '1.16', 'groupId': 'OG001', 'lowerLimit': '1.16'}, {'value': '2.0', 'spread': '1.28', 'groupId': 'OG002', 'lowerLimit': '1.28'}, {'value': '0.6', 'spread': '1.07', 'groupId': 'OG003', 'lowerLimit': '1.07'}, {'value': '0.9', 'spread': '1.28', 'groupId': 'OG004', 'lowerLimit': '1.28'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.28', 'groupId': 'OG000', 'lowerLimit': '1.28'}, {'value': '2.2', 'spread': '1.23', 'groupId': 'OG001', 'lowerLimit': '1.23'}, {'value': '1.8', 'spread': '1.36', 'groupId': 'OG002', 'lowerLimit': '1.36'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG003', 'lowerLimit': '1.03'}, {'value': '0.8', 'spread': '1.21', 'groupId': 'OG004', 'lowerLimit': '1.21'}]}]}, {'title': '9 hours post-dose', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.33', 'groupId': 'OG000', 'lowerLimit': '1.33'}, {'value': '2.1', 'spread': '1.28', 'groupId': 'OG001', 'lowerLimit': '1.28'}, {'value': '1.8', 'spread': '1.39', 'groupId': 'OG002', 'lowerLimit': '1.39'}, {'value': '0.5', 'spread': '1.02', 'groupId': 'OG003', 'lowerLimit': '1.02'}, {'value': '0.8', 'spread': '1.28', 'groupId': 'OG004', 'lowerLimit': '1.28'}]}]}, {'title': '10 hours post-dose', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.35', 'groupId': 'OG000', 'lowerLimit': '1.35'}, {'value': '2.1', 'spread': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.35'}, {'value': '1.7', 'spread': '1.42', 'groupId': 'OG002', 'lowerLimit': '1.42'}, {'value': '0.5', 'spread': '1.05', 'groupId': 'OG003', 'lowerLimit': '1.05'}, {'value': '0.8', 'spread': '1.31', 'groupId': 'OG004', 'lowerLimit': '1.31'}]}]}, {'title': '11 hours post-dose', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.38'}, {'value': '2.0', 'spread': '1.41', 'groupId': 'OG001', 'lowerLimit': '1.41'}, {'value': '1.6', 'spread': '1.45', 'groupId': 'OG002', 'lowerLimit': '1.45'}, {'value': '0.5', 'spread': '1.07', 'groupId': 'OG003', 'lowerLimit': '1.07'}, {'value': '0.8', 'spread': '1.34', 'groupId': 'OG004', 'lowerLimit': '1.34'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.4'}, {'value': '1.8', 'spread': '1.46', 'groupId': 'OG001', 'lowerLimit': '1.46'}, {'value': '1.5', 'spread': '1.47', 'groupId': 'OG002', 'lowerLimit': '1.47'}, {'value': '0.5', 'spread': '1.07', 'groupId': 'OG003', 'lowerLimit': '1.07'}, {'value': '0.8', 'spread': '1.34', 'groupId': 'OG004', 'lowerLimit': '1.34'}]}]}, {'title': '14 hours post-dose', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.44'}, {'value': '1.6', 'spread': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.51'}, {'value': '1.4', 'spread': '1.46', 'groupId': 'OG002', 'lowerLimit': '1.46'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG003', 'lowerLimit': '1.03'}, {'value': '0.8', 'spread': '1.29', 'groupId': 'OG004', 'lowerLimit': '1.29'}]}]}, {'title': '16 hours post-dose', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.45'}, {'value': '1.5', 'spread': '1.46', 'groupId': 'OG001', 'lowerLimit': '1.46'}, {'value': '1.3', 'spread': '1.44', 'groupId': 'OG002', 'lowerLimit': '1.44'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG003', 'lowerLimit': '1.03'}, {'value': '0.7', 'spread': '1.25', 'groupId': 'OG004', 'lowerLimit': '1.25'}]}]}, {'title': '18 hours post-dose', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.45'}, {'value': '1.4', 'spread': '1.44', 'groupId': 'OG001', 'lowerLimit': '1.44'}, {'value': '1.3', 'spread': '1.43', 'groupId': 'OG002', 'lowerLimit': '1.43'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG003', 'lowerLimit': '1.03'}, {'value': '0.7', 'spread': '1.25', 'groupId': 'OG004', 'lowerLimit': '1.25'}]}]}, {'title': '20 hours post-dose', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.44'}, {'value': '1.4', 'spread': '1.44', 'groupId': 'OG001', 'lowerLimit': '1.44'}, {'value': '1.3', 'spread': '1.46', 'groupId': 'OG002', 'lowerLimit': '1.46'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG003', 'lowerLimit': '1.03'}, {'value': '0.8', 'spread': '1.31', 'groupId': 'OG004', 'lowerLimit': '1.31'}]}]}, {'title': '22 hours post-dose', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.51', 'groupId': 'OG000', 'lowerLimit': '1.51'}, {'value': '1.5', 'spread': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.50'}, {'value': '1.4', 'spread': '1.51', 'groupId': 'OG002', 'lowerLimit': '1.51'}, {'value': '0.5', 'spread': '1.18', 'groupId': 'OG003', 'lowerLimit': '1.18'}, {'value': '0.9', 'spread': '1.46', 'groupId': 'OG004', 'lowerLimit': '1.46'}]}]}, {'title': '24 hours post-dose', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.53', 'groupId': 'OG000', 'lowerLimit': '1.53'}, {'value': '1.6', 'spread': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.51'}, {'value': '1.4', 'spread': '1.56', 'groupId': 'OG002', 'lowerLimit': '1.56'}, {'value': '0.5', 'spread': '1.22', 'groupId': 'OG003', 'lowerLimit': '1.22'}, {'value': '0.9', 'spread': '1.51', 'groupId': 'OG004', 'lowerLimit': '1.51'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Pain Relief Score (PRS): 0 = No Relief; 1 = A Little Relief; 2 = Some Relief; 3 = A Lot of Relief; 4 = Complete Relief.', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Pain Intensity Difference (PID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.11'}, {'value': '6.26', 'spread': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.11'}, {'value': '6.22', 'spread': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.11'}, {'value': '6.30', 'spread': '0.18', 'groupId': 'OG003', 'lowerLimit': '0.18'}, {'value': '6.33', 'spread': '0.19', 'groupId': 'OG004', 'lowerLimit': '0.19'}]}]}], 'analyses': [{'pValue': '= 0.334', 'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.783', 'groupIds': ['OG001', 'OG002'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.687', 'groupIds': ['OG002', 'OG003'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.927', 'groupIds': ['OG003', 'OG004'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.492', 'groupIds': ['OG000', 'OG002'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.836', 'groupIds': ['OG001', 'OG003'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.37', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.611', 'groupIds': ['OG000', 'OG004'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.371', 'groupIds': ['OG000', 'OG003'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.752', 'groupIds': ['OG001', 'OG004'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.321', 'groupIds': ['OG000', 'OG004'], 'paramType': 'geometric LS mean square', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'The Peak Pain Intensity (peak PID) refers to the maximum change in pain intensity from baseline observed at any post-dose time point using the Numerical Rating Scale from 0 to 10. Value of 0 score means no pain and 10 score result means the worst possible pain. Participants record their pain intensity assessment in the time frame points and the highest value is identified as the Peak Pain Intensity. A high peak pain intensuty (higher value on NRS) indicates severe pain and a less effective analgesic response, and a lower value signifies better pain control and a more effective response.', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Certain Peak Pain Relief Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'title': 'Pain relief score 4', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}, {'title': 'Pain relief score 3', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}, {'title': 'Pain relief score 2', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Pain relief score 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Number of participants with pain relief score 4, 3, 2, 1. The Peak Pain Relief Score refers to the highest level of pain relief a participant reported at any time point during the study period. It provides an overview of the maximum effectiveness of the treatment at any given point during the observation period using the Categorical Pain Relief Scale which measure the degree of pain relief using a scale from 0 to 4, in which 0 is no relief, 1 a little relief, 2 some relief, 3 a lot of relief and 4 complete relief. A high socre closer indicates significant pain relief and reflects the effectiveness of the analgesic treatment. A score closer to 0 indicates little to no pain relief and suggests limited treatment efficacy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': '0.5 hour post-dose', 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '62.8', 'groupId': 'OG001'}, {'value': '60.5', 'groupId': 'OG002'}, {'value': '32.0', 'groupId': 'OG003'}, {'value': '18.4', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 1 hour', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}, {'value': '86.4', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}, {'value': '26.5', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 1.5 hour', 'categories': [{'measurements': [{'value': '87.1', 'groupId': 'OG000'}, {'value': '94.6', 'groupId': 'OG001'}, {'value': '92.5', 'groupId': 'OG002'}, {'value': '46.0', 'groupId': 'OG003'}, {'value': '40.8', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 2 hours', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000'}, {'value': '98.0', 'groupId': 'OG001'}, {'value': '94.6', 'groupId': 'OG002'}, {'value': '64.0', 'groupId': 'OG003'}, {'value': '71.4', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 3 hours', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '98.0', 'groupId': 'OG002'}, {'value': '86.0', 'groupId': 'OG003'}, {'value': '87.8', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 4 hours', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '99.3', 'groupId': 'OG002'}, {'value': '94.0', 'groupId': 'OG003'}, {'value': '95.9', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 5 hours', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '99.3', 'groupId': 'OG002'}, {'value': '98.0', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 6 hours', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '99.3', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 7 hours', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '99.3', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 8 hours', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 9 hours', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 10 hours', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 11 hours', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 12 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 14 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 16 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 18 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 20 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 22 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}, {'title': 'less or equal 24 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 hours post-dose', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Pain Relief of the Investigational Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'title': 'poor', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}, {'title': 'fair', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'good', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'very good', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'excellent', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours post-dose', 'description': 'Number of participants with overall rating poor, fair, good, very good, excellent 24 hour post-dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 days post-dose', 'description': 'Number of participants with at least one treatment emergent adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Significant Changes in Vital Signs Since Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'OG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'OG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'OG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'classes': [{'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post-dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'FG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'FG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'FG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '142'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The clinical study was conducted at a single study site in the United States between 21 September 2022 (first participant first visit) and 29 January 2024 (last participant last visit).', 'preAssignmentDetails': 'A total of 750 participants were screened at a single study center in the United States. 541 participants were randomly assigned to study intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '541', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Naproxen Sodium/ Caffeine 220/65 mg', 'description': 'Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.'}, {'id': 'BG001', 'title': 'Naproxen Sodium/Caffeine 2x220/65 mg', 'description': 'Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.'}, {'id': 'BG002', 'title': 'Naproxen Sodium 220 mg', 'description': 'Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.'}, {'id': 'BG003', 'title': 'Caffeine 100 mg', 'description': 'Participants received one tablet Caffeine 100 mg one tablet of placebo.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Participants received two tablets of placebo.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '2.13', 'groupId': 'BG000'}, {'value': '18.1', 'spread': '1.99', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '1.84', 'groupId': 'BG002'}, {'value': '17.7', 'spread': '1.82', 'groupId': 'BG003'}, {'value': '17.9', 'spread': '2.05', 'groupId': 'BG004'}, {'value': '18.1', 'spread': '1.98', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '243', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '298', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '505', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-13', 'size': 1031541, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-07T11:35', 'hasProtocol': True}, {'date': '2024-03-11', 'size': 1071353, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-07T11:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 541}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2022-07-28', 'resultsFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-07', 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose', 'timeFrame': 'Up to 8 hours post-dose', 'description': 'Pain intensity scale is the Numerical Rating Scale measured from 0 to 10, where 0 indicates no pain and 10 means the wors pain imaginable.\n\nPain intensity Difference (PID) is calculated by subtracting the pain intensity at different time points in the post-dose time point from the pain intensity at baseline.\n\nThe summed pain intensity difference (SPID) is to be calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then summing the values over the relevant time period. For SPID (0-8), eight PIDs are summed up, which is minimally 0, if there is no pain relief or maximally 80, if there is very strong pain and significant pain relief.'}], 'secondaryOutcomes': [{'measure': 'Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose', 'timeFrame': 'from 0 to 2, 4, 6, 12 and 24 hours post-dose', 'description': 'Pain intensity scale is the Numerical Rating Scale measured from 0 to 10, where 0 indicates no pain and 10 means the wors pain imaginable.\n\nPain intensity Difference (PID) is calculated by subtracting the pain intensity at different time points in the post-dose time point from the pain intensity at baseline.\n\nThe summed pain intensity difference (SPID) is to be calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then summing the values over the relevant time period. For SPID(0-i), i PIDs are summed up, which minimally is 0, if there is no pain relief or maximally i\\*10, if there is very strong pain and significant pain relief.'}, {'measure': 'Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Total Pain Relief (TOTPAR) is a cumulative measure that evaluates the overall pain relief over a specific time frame from 0-2,0-4,0-6,0-8,0-12 and 0-24 following drug administration. It is calculated by multiplying the pain relief score from the categorical pain relief scale at each time post-dose time by multiplying the duration (in hours) since the preceding time point and then adding these values. Categorical Pain Relief Scale measure the degree of pain relief using a scale from 0 to 4, in which 0 is no relief, 1 a little relief, 2 some relief, 3 a lot of relief and 4 complete relief. Higher values of TOTPAR indicates better pain relief and suggest that the investigational product provided consistence and meaningful pain relief over the period. Low TOTPAR values indicates minimal pain relief or short-lasting efficacy.'}, {'measure': 'Time to First Use of Rescue Medication', 'timeFrame': 'Up to 24 hours post-dose'}, {'measure': 'The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period', 'timeFrame': 'Up to 24 hours post-dose'}, {'measure': 'Time to First Perceptible Relief Measured by a Stopwatch', 'timeFrame': 'Up to 24 hours post-dose'}, {'measure': 'Time to Meaningful Relief Measured by a Stopwatch', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'meaningful relief is the point when the participant perceives their pain as significant and meaningful to them using the double-stopwatched method that allows to differentiate between the onset of the analgesic effect (first perceptible pain relief) and the onset of meaningful pain relief'}, {'measure': 'Time to First Perceptible Relief Confirmed by Meaningful Relief Defined as the Time to Perceptible Pain Relief', 'timeFrame': 'Up to 24 hours post-dose'}, {'measure': 'Pain Intensity Difference (PID)', 'timeFrame': 'up to 24 hours post-dose', 'description': 'Pain Intensity Difference (PID) is the change of pain intensity at a specific time point compared to baseline using the Numerical Rating Scale from 0 to 10. Value of 0 score means no pain and 10 score result means the worst possible pain. For each post-dose time point, pain intensity differences will be derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score. Positive PID values indicate pain relief (reduction in pain intensity), while negative or small PID values suggest little or no reduction in pain intensity'}, {'measure': 'Pain Relief Score', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Pain Relief Score (PRS): 0 = No Relief; 1 = A Little Relief; 2 = Some Relief; 3 = A Lot of Relief; 4 = Complete Relief.'}, {'measure': 'Peak Pain Intensity Difference (PID)', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'The Peak Pain Intensity (peak PID) refers to the maximum change in pain intensity from baseline observed at any post-dose time point using the Numerical Rating Scale from 0 to 10. Value of 0 score means no pain and 10 score result means the worst possible pain. Participants record their pain intensity assessment in the time frame points and the highest value is identified as the Peak Pain Intensity. A high peak pain intensuty (higher value on NRS) indicates severe pain and a less effective analgesic response, and a lower value signifies better pain control and a more effective response.'}, {'measure': 'Number of Participants With Certain Peak Pain Relief Score', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Number of participants with pain relief score 4, 3, 2, 1. The Peak Pain Relief Score refers to the highest level of pain relief a participant reported at any time point during the study period. It provides an overview of the maximum effectiveness of the treatment at any given point during the observation period using the Categorical Pain Relief Scale which measure the degree of pain relief using a scale from 0 to 4, in which 0 is no relief, 1 a little relief, 2 some relief, 3 a lot of relief and 4 complete relief. A high socre closer indicates significant pain relief and reflects the effectiveness of the analgesic treatment. A score closer to 0 indicates little to no pain relief and suggests limited treatment efficacy.'}, {'measure': "Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time", 'timeFrame': 'Up to 24 hours post-dose'}, {'measure': 'Global Assessment of Pain Relief of the Investigational Product', 'timeFrame': '24 hours post-dose', 'description': 'Number of participants with overall rating poor, fair, good, very good, excellent 24 hour post-dose'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to 5 days post-dose', 'description': 'Number of participants with at least one treatment emergent adverse event'}, {'measure': 'Number of Participants With Significant Changes in Vital Signs Since Baseline', 'timeFrame': 'Up to 5 days post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental pain'], 'conditions': ['Postoperative Dental Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking for a better way to relieve pain in people, such as after dental surgery.\n\nParticipants in this study, have had 3 or 4 third molars (cheek teeth) removed and subsequently have moderate to severe tooth pain.\n\nThe study treatment naproxen sodium suppresses inflammatory pain by reducing inflammation.\n\nIn the US, naproxen has been marketed since 1976, and naproxen sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea, or cocoa, has been shown to enhance the effect of various painkillers, and therefore is accepted as an additive.\n\nThe main purpose of this study is to learn how well a fixed-dose combination of naproxen sodium and caffeine relieves pain compared to each single ingredient as well as to placebo in participants after molar removal.\n\nA placebo is a treatment that looks like a medicine but does not have any medicine in it.\n\nTo answer this, the researchers will compare the amount of pain decrease over 8 hours in participants who received a single dose of either:\n\n* 1 fixed-dose tablet of naproxen sodium/caffeine\n* 2 fixed-dose tablets of naproxen sodium/caffeine\n* naproxen sodium only\n* caffeine only\n* or placebo The study participants will be randomly (by chance) assigned to one of the five treatment groups. They will take a single dose of two tablets by mouth within 4.5 hours after the surgery. If there is no pain relief within 2 hours after intake, other painkillers may be given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy, ambulatory, male or female volunteers 16 years of age or older;\n* Body mass index (BMI) 18.5 to 35.0 kg/m\\^2 inclusive as measured by the National Institutes of Health (NIH) BMI Calculator;\n* Participants will undergo surgical extraction of three or four third molars, two of which must be mandibular molars. Maxillary third molars may be removed regardless of impaction level. The mandibular extractions must have a trauma rating of mild or moderate and meet one of the following scenarios: two full bony impactions; two partial bony impactions; one full bony impaction in combination with one partial bony impaction. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;\n* Have not taken any form of medication, nutritional supplements with analgesic properties (e.g. gamma-Aminobutyric acid \\[GABA\\], turmeric) or herbal supplements (i.e., St. John's Wort) within 5 days of admission (except for oral contraceptives, prophylactic antibiotics, multivitamin supplements, or other routine medications to treat benign conditions (such as antibiotics to treat acne), and agree not to take any medication (other than that provided to them) throughout the study;\n* Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without a vasoconstrictor and nitrous oxide at the discretion of the Investigator;\n* Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 5 on the 0-10 pain intensity Numerical Rating Scale (NRS) within 4.5 hours post-surgery.\n\nExclusion Criteria:\n\n* History of hypersensitivity to naproxen sodium, caffeine, ibuprofen, nonsteroidal anti-inflammatory drug (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;\n* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension and cardiac arrhythmia), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;\n* Participants with the following medical conditions may be eligible at the discretion of the investigator: attention deficit hyperactivity disorder (ADHD) on a stable dose regimen of methylphenidate/(dextro) amphetamine for at least 6 months; participants with hypothyroidism on a stable dose of synthetic thyroid hormone for at least 6 months;\n* Have received any form of treatment in the form of medication for depression in the past 6 months or any form of psychotropic agent (including selective serotonin uptake inhibitors \\[SSRI\\] but excluding ADHD medications described above) within the last 6 months;\n* Relevant concomitant disease such as asthma (exercise induced asthma is permitted);\n* Current or past history of gastrointestinal ulceration, gastrointestinal bleeding or other bleeding disorder(s);\n* Acute illness or active local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator;\n* Use of any over-the-counter (OTC) or prescription medications with which the administration of naproxen, acetaminophen, ibuprofen, any other NSAID, (e.g., tramadol) or if a medication is contraindicated;\n* Use of any medications within 5 days of surgery until discharge from the study site (except oral contraceptives, prophylactic antibiotics, synthetic thyroid hormones, methylphenidate or medications to treat benign conditions such as antibiotics to treat acne);\n* Use of caffeine within 2 days prior to the study;\n* Habits of high consumption of caffeine (\\>400 mg/day equivalent to about 3-4 cups of coffee per day);\n* Habituation to analgesic drugs including opioids (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks within the past 2 years);\n* Surgeon's trauma rating of severe following surgery."}, 'identificationModule': {'nctId': 'NCT05485805', 'briefTitle': 'A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Pivotal Trial to Confirm the Efficacy of a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain', 'orgStudyIdInfo': {'id': '22093'}, 'secondaryIdInfos': [{'id': '2022-003274-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium/caffeine - Dose 1', 'description': 'Participants will receive a single dose of one tablet of naproxen sodium/caffeine plus one tablet of placebo after extraction of third molars.', 'interventionNames': ['Drug: Naproxen sodium and caffeine (BAY2880376)']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium/caffeine - Dose 2', 'description': 'Participants will receive a single dose of two tablets of naproxen sodium/caffeine after extraction of third molars.', 'interventionNames': ['Drug: Naproxen sodium and caffeine (BAY2880376)']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium', 'description': 'Participants will receive a single dose of one tablet of naproxen sodium plus one tablet of placebo after extraction of third molars.', 'interventionNames': ['Drug: Naproxen sodium (Aleve)']}, {'type': 'EXPERIMENTAL', 'label': 'Caffeine', 'description': 'Participants will receive a single dose of two tablets of caffeine after extraction of third molars.', 'interventionNames': ['Drug: Caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single dose of two tablets of matching placebo after extraction of third molars.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naproxen sodium and caffeine (BAY2880376)', 'type': 'DRUG', 'description': 'Tablet, oral use, single dose', 'armGroupLabels': ['Naproxen sodium/caffeine - Dose 1', 'Naproxen sodium/caffeine - Dose 2']}, {'name': 'Naproxen sodium (Aleve)', 'type': 'DRUG', 'description': 'Tablet, oral use, single dose', 'armGroupLabels': ['Naproxen sodium']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'Tablet, oral use, single dose', 'armGroupLabels': ['Caffeine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet, oral use, single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}