Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
Study NCT ID:
NCT00333866
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2006-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Organization: Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.', 'otherNumAtRisk': 184, 'otherNumAffected': 97, 'seriousNumAtRisk': 184, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.', 'otherNumAtRisk': 184, 'otherNumAffected': 137, 'seriousNumAtRisk': 184, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.', 'otherNumAtRisk': 182, 'otherNumAffected': 141, 'seriousNumAtRisk': 182, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.', 'otherNumAtRisk': 186, 'otherNumAffected': 154, 'seriousNumAtRisk': 186, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 15}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 93}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vascular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-1.29', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '-0.96', 'spread': '0.14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2361', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.15', 'groupDescription': 'P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': "Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented."}, {'pValue': '0.0132', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.17', 'groupDescription': 'P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': "Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented."}, {'pValue': '0.1694', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.05', 'groupDescription': 'P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': "Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Patient Global Impression of Change (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0227', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0017', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0768', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': "Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.72', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.95', 'spread': '0.15', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.01', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '-0.60', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '-0.37', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.07', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Mean Sleep Quality Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'title': 'Week 1 (n=183,179,174,178)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.08', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.23', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n=180,172,168,174)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.43', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.59', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n=174, 164, 159,163)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.90', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n=165,157,155,156)', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-2.01', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 5 (n=163, 150, 152,148)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.99', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 6 (n=159,145,148,144)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.76', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.15', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Week 7 (n=155,140,144,133)', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-1.83', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.20', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=149,133,142,127)', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.25', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Week 9 (n=146,128,141,126)', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-1.94', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.24', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 (n=144,125,139,126)', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-2.03', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.34', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Week 11 (n=143,123,137,121)', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.24', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=141,121,135,119)', 'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-2.29', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Week 13 (n=140,120,133,118)', 'categories': [{'measurements': [{'value': '-1.05', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-2.26', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Week 14 (n=134,115,128,111)', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-2.29', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': 'Overall (n=183,179,174,178)', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.76', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '-2.07', 'spread': '0.12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.8', 'groupDescription': 'Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciPctValue': '95', 'paramValue': '-1.28', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.8', 'groupDescription': 'Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.12', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.7', 'groupDescription': 'Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.8', 'groupDescription': 'Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.7', 'groupDescription': 'Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.0', 'groupDescription': 'Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.8', 'groupDescription': 'Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.8', 'groupDescription': 'Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.9', 'groupDescription': 'Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.6', 'groupDescription': 'Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.4', 'groupDescription': 'Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.', 'statisticalMethod': 'Mixed Model Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14', 'description': 'Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Optimal Sleep Assessed Using MOS-SS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}, {'value': '44.0', 'groupId': 'OG002'}, {'value': '32.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5370', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.95', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0109', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.16', 'ciUpperLimit': '3.18', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.68', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 14', 'description': 'Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\\*100);total score range:0-100,higher score=more disturbance.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'title': 'Sleep Disturbance (n=183,183,177,185)', 'categories': [{'measurements': [{'value': '-5.99', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-13.18', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '-19.26', 'spread': '1.84', 'groupId': 'OG002'}, {'value': '-18.70', 'spread': '1.78', 'groupId': 'OG003'}]}]}, {'title': 'Snoring (n=172,174,174,177)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '4.89', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '5.87', 'spread': '1.73', 'groupId': 'OG003'}]}]}, {'title': 'Shortness of Breath, Headache (n=182,182,177,184)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-9.62', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '-12.59', 'spread': '1.96', 'groupId': 'OG002'}, {'value': '-9.91', 'spread': '1.91', 'groupId': 'OG003'}]}]}, {'title': 'Quantity of Sleep (n=182,182,175,182)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '0.11', 'groupId': 'OG002'}, {'value': '0.76', 'spread': '0.10', 'groupId': 'OG003'}]}]}, {'title': 'Sleep Adequacy (n=183,183,179,185)', 'categories': [{'measurements': [{'value': '7.62', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '10.19', 'spread': '1.92', 'groupId': 'OG001'}, {'value': '16.76', 'spread': '1.96', 'groupId': 'OG002'}, {'value': '11.97', 'spread': '1.92', 'groupId': 'OG003'}]}]}, {'title': 'Somnolence (n=182,182,177,184)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '1.53', 'groupId': 'OG002'}, {'value': '1.92', 'spread': '1.49', 'groupId': 'OG003'}]}]}, {'title': 'Overall Sleep Problem Index (n=181,181,174,184)', 'categories': [{'measurements': [{'value': '-4.83', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-9.19', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '-13.07', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '-11.72', 'spread': '1.34', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.71', 'ciLowerLimit': '-17.56', 'ciUpperLimit': '-7.86', 'groupDescription': 'Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.28', 'ciLowerLimit': '-18.18', 'ciUpperLimit': '-8.38', 'groupDescription': 'Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.20', 'ciLowerLimit': '-12.06', 'ciUpperLimit': '-2.33', 'groupDescription': 'Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0142', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.90', 'ciLowerLimit': '1.19', 'ciUpperLimit': '10.61', 'groupDescription': 'Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0414', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.92', 'ciLowerLimit': '0.19', 'ciUpperLimit': '9.66', 'groupDescription': 'Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '-3.53', 'ciUpperLimit': '5.95', 'groupDescription': 'Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.24', 'ciLowerLimit': '-14.44', 'ciUpperLimit': '-4.05', 'groupDescription': 'Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciPctValue': '95', 'paramValue': '-11.92', 'ciLowerLimit': '-17.17', 'ciUpperLimit': '-6.68', 'groupDescription': 'Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.95', 'ciLowerLimit': '-14.16', 'ciUpperLimit': '-3.74', 'groupDescription': 'Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0127', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.64', 'groupDescription': 'Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.79', 'groupDescription': 'Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1453', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.49', 'groupDescription': 'Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1033', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.34', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '9.57', 'groupDescription': 'Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.14', 'ciLowerLimit': '3.88', 'ciUpperLimit': '14.41', 'groupDescription': 'Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '7.81', 'groupDescription': 'Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3308', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '6.07', 'groupDescription': 'Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7364', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '-3.39', 'ciUpperLimit': '4.80', 'groupDescription': 'Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '-3.31', 'ciUpperLimit': '4.84', 'groupDescription': 'Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.90', 'ciLowerLimit': '-10.54', 'ciUpperLimit': '-3.25', 'groupDescription': 'Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.25', 'ciLowerLimit': '-11.94', 'ciUpperLimit': '-4.55', 'groupDescription': 'Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.36', 'ciLowerLimit': '-8.02', 'ciUpperLimit': '-0.70', 'groupDescription': 'Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\\*100);total score range:0-100,higher score=more intensity of attribute.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'title': 'FIQ Physical Impairment (n=183,184,179,186)', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.14', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Feel Good (n=182,184,178,183)', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-1.77', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-1.26', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Work Missed (n=182,181,178,184)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-0.27', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Do Work (n=182,183,179,185)', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-1.60', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.98', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Pain (n=183,184,179,185)', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.72', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-1.10', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Fatigue (n=183,184,179,184)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-1.36', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-1.05', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Rested (n=183,184,179,185)', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-1.47', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-1.40', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Stiffness (n=183,184,179,185)', 'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '0.18', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Anxiety (n=183,184,179,185)', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '0.20', 'groupId': 'OG003'}]}]}, {'title': 'FIQ Depression (n=181,184,179,184)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-1.19', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-0.43', 'spread': '0.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3627', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.20', 'groupDescription': 'FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1686', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.11', 'groupDescription': 'FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3468', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.19', 'groupDescription': 'FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7147', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.49', 'groupDescription': 'FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0409', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '-0.03', 'groupDescription': 'FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.63', 'groupDescription': 'FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5923', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.37', 'groupDescription': 'FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0174', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '-0.11', 'groupDescription': 'FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.35', 'groupDescription': 'FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7236', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.40', 'groupDescription': 'FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0045', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.22', 'groupDescription': 'FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.34', 'groupDescription': 'FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5609', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.33', 'groupDescription': 'FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '-0.28', 'groupDescription': 'FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3692', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.25', 'groupDescription': 'FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3294', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.25', 'groupDescription': 'FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0270', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.06', 'groupDescription': 'FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8432', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.44', 'groupDescription': 'FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0806', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.06', 'groupDescription': 'FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0470', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.01', 'groupDescription': 'FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.29', 'groupDescription': 'FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6326', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.60', 'groupDescription': 'FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3740', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.27', 'groupDescription': 'FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8936', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.52', 'groupDescription': 'FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4743', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.34', 'groupDescription': 'FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0192', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '-0.10', 'groupDescription': 'FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.35', 'groupDescription': 'FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4617', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.34', 'groupDescription': 'FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.42', 'groupDescription': 'FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2290', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.21', 'groupDescription': 'FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.94', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-8.11', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-12.79', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '-8.38', 'spread': '1.29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4200', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-4.95', 'ciUpperLimit': '2.06', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.85', 'ciLowerLimit': '-9.38', 'ciUpperLimit': '-2.31', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-4.68', 'ciUpperLimit': '2.34', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'title': 'Physical Functioning (n=184,184,177,186)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '6.63', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '4.13', 'spread': '1.31', 'groupId': 'OG003'}]}]}, {'title': 'Physical Role Limitations (n=183,183,177,185)', 'categories': [{'measurements': [{'value': '4.01', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '5.50', 'spread': '1.66', 'groupId': 'OG002'}, {'value': '5.03', 'spread': '1.62', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Role Limitations (n=183,183,177,185)', 'categories': [{'measurements': [{'value': '-2.31', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '1.93', 'groupId': 'OG001'}, {'value': '3.93', 'spread': '1.98', 'groupId': 'OG002'}, {'value': '1.56', 'spread': '1.93', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning (n=183,184,178,186)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '5.76', 'spread': '1.81', 'groupId': 'OG002'}, {'value': '3.60', 'spread': '1.76', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health (n=183,184,178,186)', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '4.25', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '2.41', 'spread': '1.34', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain (n=183,184,178,186)', 'categories': [{'measurements': [{'value': '4.95', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '10.32', 'spread': '1.33', 'groupId': 'OG002'}, {'value': '7.53', 'spread': '1.30', 'groupId': 'OG003'}]}]}, {'title': 'Vitality (n=183,184,178,186)', 'categories': [{'measurements': [{'value': '4.15', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '9.25', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '7.29', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'General Health Perception (n=183,184,177,186)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '3.67', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '2.21', 'spread': '1.14', 'groupId': 'OG003'}]}]}, {'title': 'Mental Component Score (n=182,183,176,184)', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '2.39', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '1.35', 'spread': '0.81', 'groupId': 'OG003'}]}]}, {'title': 'Physical Component Score (n=182,183,176,184)', 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '3.01', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '2.34', 'spread': '0.52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7781', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-4.07', 'ciUpperLimit': '3.05', 'groupDescription': 'Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2792', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '5.59', 'groupDescription': 'Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7512', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '-3.00', 'ciUpperLimit': '4.15', 'groupDescription': 'Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6490', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '-3.39', 'ciUpperLimit': '5.43', 'groupDescription': 'Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5105', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '-2.96', 'ciUpperLimit': '5.96', 'groupDescription': 'Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8625', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-4.04', 'ciUpperLimit': '4.82', 'groupDescription': 'Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1489', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.87', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '9.12', 'groupDescription': 'Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0213', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.24', 'ciLowerLimit': '0.93', 'ciUpperLimit': '11.54', 'groupDescription': 'Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1620', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.75', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '9.02', 'groupDescription': 'Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2446', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '7.65', 'groupDescription': 'Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0429', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.01', 'ciLowerLimit': '0.16', 'ciUpperLimit': '9.85', 'groupDescription': 'Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.35', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '8.16', 'groupDescription': 'Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0291', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.08', 'ciLowerLimit': '0.42', 'ciUpperLimit': '7.74', 'groupDescription': 'Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0017', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.93', 'ciLowerLimit': '2.23', 'ciUpperLimit': '9.62', 'groupDescription': 'Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.32', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '6.99', 'groupDescription': 'Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1524', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.58', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '6.11', 'groupDescription': 'Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0032', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.36', 'ciLowerLimit': '1.80', 'ciUpperLimit': '8.93', 'groupDescription': 'Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1180', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.82', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '6.36', 'groupDescription': 'Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1081', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.15', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '6.99', 'groupDescription': 'Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0101', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.10', 'ciLowerLimit': '1.22', 'ciUpperLimit': '8.99', 'groupDescription': 'Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '-3.10', 'ciUpperLimit': '4.60', 'groupDescription': 'Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4253', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '-1.86', 'ciUpperLimit': '4.39', 'groupDescription': 'General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0910', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.73', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '5.89', 'groupDescription': 'General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '4.95', 'groupDescription': 'General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0195', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.62', 'ciLowerLimit': '0.42', 'ciUpperLimit': '4.82', 'groupDescription': 'Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.66', 'ciLowerLimit': '1.44', 'ciUpperLimit': '5.88', 'groupDescription': 'Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0568', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.14', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '4.34', 'groupDescription': 'Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8529', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '1.27', 'groupDescription': 'Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4564', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '1.96', 'groupDescription': 'Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '1.54', 'groupDescription': 'Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-3.32', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-2.19', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7384', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-1.98', 'ciUpperLimit': '1.40', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1044', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.41', 'ciLowerLimit': '-3.12', 'ciUpperLimit': '0.29', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3137', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '0.83', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'title': 'HADS Anxiety (HADS-A) Total', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '-0.90', 'spread': '0.25', 'groupId': 'OG003'}]}]}, {'title': 'HADS Depression (HADS-D) Total', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0900', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '0.09', 'groupDescription': 'HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1564', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '0.19', 'groupDescription': 'HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7519', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.58', 'groupDescription': 'HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6416', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.80', 'groupDescription': 'HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0778', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.07', 'groupDescription': 'HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.44', 'groupDescription': 'HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.30', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-12.86', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '-17.75', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '-11.74', 'spread': '1.66', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5340', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-5.97', 'ciUpperLimit': '3.09', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.44', 'ciLowerLimit': '-12.00', 'ciUpperLimit': '-2.88', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2694', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-7.09', 'ciUpperLimit': '1.98', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Total Daily Acetaminophen Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '460.65', 'spread': '125.43', 'groupId': 'OG000'}, {'value': '449.14', 'spread': '124.79', 'groupId': 'OG001'}, {'value': '508.53', 'spread': '126.71', 'groupId': 'OG002'}, {'value': '724.42', 'spread': '124.72', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1277', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '263.77', 'ciLowerLimit': '-75.78', 'ciUpperLimit': '603.33', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7829', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.89', 'ciLowerLimit': '-293.2', 'ciUpperLimit': '389.02', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.51', 'ciLowerLimit': '-351.9', 'ciUpperLimit': '328.86', 'groupDescription': 'P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 14', 'description': 'Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'FG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'FG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'FG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '187'}, {'groupId': 'FG002', 'numSubjects': '184'}, {'groupId': 'FG003', 'numSubjects': '187'}]}, {'type': 'TREATED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '182'}, {'groupId': 'FG003', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '133'}, {'groupId': 'FG003', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment from 73 centers in North America \\[Canada (12) and Mexico (4)\\], South America \\[Venezuela (3)\\], Europe \\[Denmark (2), France (5), Germany (5), Italy (6), Netherlands (5), Portugal (4), Spain (4), Sweden (4), Switzerland (3) and United Kingdom(5)\\] and Asia \\[India (4) and Korea (3)\\] and Australia (4).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '736', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to pregabalin capsules orally twice daily up to Week 14.'}, {'id': 'BG001', 'title': 'Pregabalin 300 mg', 'description': 'Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'BG002', 'title': 'Pregabalin 450 mg', 'description': 'Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'BG003', 'title': 'Pregabalin 600 mg', 'description': 'Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '49.6', 'spread': '11.3', 'groupId': 'BG003'}, {'value': '48.5', 'spread': '11.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}, {'value': '673', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Pain Score', 'classes': [{'categories': [{'measurements': [{'value': '6.68', 'spread': '1.48', 'groupId': 'BG000'}, {'value': '6.76', 'spread': '1.29', 'groupId': 'BG001'}, {'value': '6.57', 'spread': '1.31', 'groupId': 'BG002'}, {'value': '6.59', 'spread': '1.37', 'groupId': 'BG003'}, {'value': '6.65', 'spread': '1.36', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Daily pain diary consists of 11-point numeric rating scale (NRS) ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Number of participants evaluable=184,184,181,186.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Sleep Quality Score', 'classes': [{'categories': [{'measurements': [{'value': '6.01', 'spread': '1.90', 'groupId': 'BG000'}, {'value': '5.94', 'spread': '1.70', 'groupId': 'BG001'}, {'value': '5.94', 'spread': '1.70', 'groupId': 'BG002'}, {'value': '5.91', 'spread': '1.80', 'groupId': 'BG003'}, {'value': '5.95', 'spread': '1.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. Number of participants evaluable=184,184,181,186.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of Participants With Optimal Sleep Assessed Using MOS-SS', 'classes': [{'categories': [{'measurements': [{'value': '20.33', 'groupId': 'BG000'}, {'value': '25.27', 'groupId': 'BG001'}, {'value': '24.57', 'groupId': 'BG002'}, {'value': '17.03', 'groupId': 'BG003'}, {'value': '87.2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. Number of participants evaluable=182,182,175,182.', 'unitOfMeasure': 'Percentage of Participants'}, {'title': 'Medical Outcome Study Sleep Scale (MOS-SS)', 'classes': [{'title': 'Sleep Disturbance', 'categories': [{'measurements': [{'value': '60.02', 'spread': '25.60', 'groupId': 'BG000'}, {'value': '61.86', 'spread': '25.80', 'groupId': 'BG001'}, {'value': '59.59', 'spread': '26.55', 'groupId': 'BG002'}, {'value': '60.37', 'spread': '25.09', 'groupId': 'BG003'}, {'value': '60.47', 'spread': '25.72', 'groupId': 'BG004'}]}]}, {'title': 'Snoring', 'categories': [{'measurements': [{'value': '31.05', 'spread': '32.39', 'groupId': 'BG000'}, {'value': '32.53', 'spread': '30.82', 'groupId': 'BG001'}, {'value': '29.77', 'spread': '32.52', 'groupId': 'BG002'}, {'value': '32.09', 'spread': '32.20', 'groupId': 'BG003'}, {'value': '31.36', 'spread': '31.94', 'groupId': 'BG004'}]}]}, {'title': 'Shortness of Breath, Headache', 'categories': [{'measurements': [{'value': '34.18', 'spread': '32.96', 'groupId': 'BG000'}, {'value': '36.70', 'spread': '31.01', 'groupId': 'BG001'}, {'value': '38.31', 'spread': '32.46', 'groupId': 'BG002'}, {'value': '37.07', 'spread': '31.54', 'groupId': 'BG003'}, {'value': '36.55', 'spread': '31.97', 'groupId': 'BG004'}]}]}, {'title': 'Quantity of Sleep', 'categories': [{'measurements': [{'value': '5.47', 'spread': '1.54', 'groupId': 'BG000'}, {'value': '5.59', 'spread': '1.66', 'groupId': 'BG001'}, {'value': '5.61', 'spread': '1.68', 'groupId': 'BG002'}, {'value': '5.45', 'spread': '1.65', 'groupId': 'BG003'}, {'value': '5.53', 'spread': '1.63', 'groupId': 'BG004'}]}]}, {'title': 'Sleep Adequacy', 'categories': [{'measurements': [{'value': '24.70', 'spread': '23.39', 'groupId': 'BG000'}, {'value': '24.43', 'spread': '24.80', 'groupId': 'BG001'}, {'value': '24.30', 'spread': '22.83', 'groupId': 'BG002'}, {'value': '25.03', 'spread': '24.25', 'groupId': 'BG003'}, {'value': '24.62', 'spread': '23.79', 'groupId': 'BG004'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '41.68', 'spread': '21.78', 'groupId': 'BG000'}, {'value': '44.03', 'spread': '22.80', 'groupId': 'BG001'}, {'value': '42.37', 'spread': '23.91', 'groupId': 'BG002'}, {'value': '42.97', 'spread': '23.92', 'groupId': 'BG003'}, {'value': '42.77', 'spread': '23.09', 'groupId': 'BG004'}]}]}, {'title': 'Overall Sleep Problem Index', 'categories': [{'measurements': [{'value': '57.46', 'spread': '17.27', 'groupId': 'BG000'}, {'value': '59.27', 'spread': '19.24', 'groupId': 'BG001'}, {'value': '58.11', 'spread': '18.94', 'groupId': 'BG002'}, {'value': '58.05', 'spread': '18.12', 'groupId': 'BG003'}, {'value': '58.22', 'spread': '18.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\\*100);total score range:0-100,higher score=more intensity of attribute. Number of participants evaluable=183,183,177,185.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores', 'classes': [{'title': 'FIQ Physical Impairment', 'categories': [{'measurements': [{'value': '4.04', 'spread': '2.18', 'groupId': 'BG000'}, {'value': '3.88', 'spread': '2.13', 'groupId': 'BG001'}, {'value': '3.87', 'spread': '2.12', 'groupId': 'BG002'}, {'value': '3.75', 'spread': '2.15', 'groupId': 'BG003'}, {'value': '3.88', 'spread': '2.14', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Feel Good', 'categories': [{'measurements': [{'value': '7.50', 'spread': '2.61', 'groupId': 'BG000'}, {'value': '7.46', 'spread': '2.77', 'groupId': 'BG001'}, {'value': '7.63', 'spread': '2.53', 'groupId': 'BG002'}, {'value': '7.77', 'spread': '2.65', 'groupId': 'BG003'}, {'value': '7.59', 'spread': '2.64', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Work Missed', 'categories': [{'measurements': [{'value': '3.38', 'spread': '3.34', 'groupId': 'BG000'}, {'value': '3.35', 'spread': '3.18', 'groupId': 'BG001'}, {'value': '3.22', 'spread': '3.36', 'groupId': 'BG002'}, {'value': '2.86', 'spread': '2.99', 'groupId': 'BG003'}, {'value': '3.20', 'spread': '3.22', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Do Work', 'categories': [{'measurements': [{'value': '6.96', 'spread': '2.24', 'groupId': 'BG000'}, {'value': '6.54', 'spread': '2.23', 'groupId': 'BG001'}, {'value': '6.68', 'spread': '1.96', 'groupId': 'BG002'}, {'value': '6.62', 'spread': '2.01', 'groupId': 'BG003'}, {'value': '6.70', 'spread': '2.12', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Pain', 'categories': [{'measurements': [{'value': '7.35', 'spread': '1.63', 'groupId': 'BG000'}, {'value': '7.24', 'spread': '1.48', 'groupId': 'BG001'}, {'value': '7.09', 'spread': '1.62', 'groupId': 'BG002'}, {'value': '7.15', 'spread': '1.60', 'groupId': 'BG003'}, {'value': '7.21', 'spread': '1.58', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Fatigue', 'categories': [{'measurements': [{'value': '7.85', 'spread': '1.84', 'groupId': 'BG000'}, {'value': '7.45', 'spread': '2.14', 'groupId': 'BG001'}, {'value': '7.34', 'spread': '2.02', 'groupId': 'BG002'}, {'value': '7.56', 'spread': '2.04', 'groupId': 'BG003'}, {'value': '7.55', 'spread': '2.02', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Rested', 'categories': [{'measurements': [{'value': '7.71', 'spread': '2.03', 'groupId': 'BG000'}, {'value': '7.61', 'spread': '2.08', 'groupId': 'BG001'}, {'value': '7.55', 'spread': '1.96', 'groupId': 'BG002'}, {'value': '7.44', 'spread': '2.02', 'groupId': 'BG003'}, {'value': '7.58', 'spread': '2.02', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Stiffness', 'categories': [{'measurements': [{'value': '7.52', 'spread': '2.13', 'groupId': 'BG000'}, {'value': '7.19', 'spread': '2.07', 'groupId': 'BG001'}, {'value': '7.03', 'spread': '2.02', 'groupId': 'BG002'}, {'value': '7.28', 'spread': '2.24', 'groupId': 'BG003'}, {'value': '7.26', 'spread': '2.12', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Anxiety', 'categories': [{'measurements': [{'value': '5.38', 'spread': '3.09', 'groupId': 'BG000'}, {'value': '5.27', 'spread': '2.96', 'groupId': 'BG001'}, {'value': '5.35', 'spread': '2.86', 'groupId': 'BG002'}, {'value': '5.35', 'spread': '2.97', 'groupId': 'BG003'}, {'value': '5.34', 'spread': '2.97', 'groupId': 'BG004'}]}]}, {'title': 'FIQ Depression', 'categories': [{'measurements': [{'value': '4.85', 'spread': '3.12', 'groupId': 'BG000'}, {'value': '4.73', 'spread': '2.93', 'groupId': 'BG001'}, {'value': '4.79', 'spread': '3.01', 'groupId': 'BG002'}, {'value': '4.65', 'spread': '3.00', 'groupId': 'BG003'}, {'value': '4.76', 'spread': '3.01', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. Number of participants evaluable=183,184,179,186.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fibromyalgia Impact Questionnaire (FIQ) Total Scores', 'classes': [{'categories': [{'measurements': [{'value': '62.58', 'spread': '14.85', 'groupId': 'BG000'}, {'value': '60.75', 'spread': '14.77', 'groupId': 'BG001'}, {'value': '60.59', 'spread': '14.59', 'groupId': 'BG002'}, {'value': '60.40', 'spread': '13.87', 'groupId': 'BG003'}, {'value': '61.08', 'spread': '14.52', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. Number of participants evaluable=184,184,179,186.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '36-Item Short-Form Health Survey (SF-36)', 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '42.93', 'spread': '21.04', 'groupId': 'BG000'}, {'value': '44.71', 'spread': '20.29', 'groupId': 'BG001'}, {'value': '42.52', 'spread': '22.17', 'groupId': 'BG002'}, {'value': '43.54', 'spread': '20.39', 'groupId': 'BG003'}, {'value': '43.43', 'spread': '20.94', 'groupId': 'BG004'}]}]}, {'title': 'Physical Role Limitations', 'categories': [{'measurements': [{'value': '37.14', 'spread': '22.75', 'groupId': 'BG000'}, {'value': '40.79', 'spread': '25.58', 'groupId': 'BG001'}, {'value': '41.44', 'spread': '25.39', 'groupId': 'BG002'}, {'value': '39.46', 'spread': '24.71', 'groupId': 'BG003'}, {'value': '39.69', 'spread': '24.63', 'groupId': 'BG004'}]}]}, {'title': 'Emotional Role Limitations', 'categories': [{'measurements': [{'value': '59.61', 'spread': '29.52', 'groupId': 'BG000'}, {'value': '60.61', 'spread': '29.23', 'groupId': 'BG001'}, {'value': '61.54', 'spread': '28.94', 'groupId': 'BG002'}, {'value': '61.31', 'spread': '29.50', 'groupId': 'BG003'}, {'value': '60.76', 'spread': '29.25', 'groupId': 'BG004'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '54.44', 'spread': '26.95', 'groupId': 'BG000'}, {'value': '56.79', 'spread': '26.00', 'groupId': 'BG001'}, {'value': '53.93', 'spread': '26.55', 'groupId': 'BG002'}, {'value': '53.70', 'spread': '25.55', 'groupId': 'BG003'}, {'value': '54.72', 'spread': '26.24', 'groupId': 'BG004'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '56.48', 'spread': '20.68', 'groupId': 'BG000'}, {'value': '56.41', 'spread': '20.49', 'groupId': 'BG001'}, {'value': '57.56', 'spread': '21.70', 'groupId': 'BG002'}, {'value': '56.71', 'spread': '20.39', 'groupId': 'BG003'}, {'value': '56.78', 'spread': '20.77', 'groupId': 'BG004'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '29.28', 'spread': '15.61', 'groupId': 'BG000'}, {'value': '28.67', 'spread': '13.65', 'groupId': 'BG001'}, {'value': '28.30', 'spread': '13.62', 'groupId': 'BG002'}, {'value': '28.70', 'spread': '13.20', 'groupId': 'BG003'}, {'value': '28.74', 'spread': '14.03', 'groupId': 'BG004'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '26.46', 'spread': '16.76', 'groupId': 'BG000'}, {'value': '27.88', 'spread': '17.67', 'groupId': 'BG001'}, {'value': '28.78', 'spread': '19.94', 'groupId': 'BG002'}, {'value': '27.42', 'spread': '19.14', 'groupId': 'BG003'}, {'value': '27.63', 'spread': '18.39', 'groupId': 'BG004'}]}]}, {'title': 'General Health Perception', 'categories': [{'measurements': [{'value': '41.65', 'spread': '18.35', 'groupId': 'BG000'}, {'value': '42.12', 'spread': '19.24', 'groupId': 'BG001'}, {'value': '45.56', 'spread': '18.56', 'groupId': 'BG002'}, {'value': '44.58', 'spread': '18.23', 'groupId': 'BG003'}, {'value': '43.47', 'spread': '18.63', 'groupId': 'BG004'}]}]}, {'title': 'Mental Component Score', 'categories': [{'measurements': [{'value': '40.11', 'spread': '11.57', 'groupId': 'BG000'}, {'value': '40.45', 'spread': '11.72', 'groupId': 'BG001'}, {'value': '40.79', 'spread': '13.15', 'groupId': 'BG002'}, {'value': '40.37', 'spread': '12.14', 'groupId': 'BG003'}, {'value': '40.43', 'spread': '12.13', 'groupId': 'BG004'}]}]}, {'title': 'Physical Component Score', 'categories': [{'measurements': [{'value': '31.87', 'spread': '7.59', 'groupId': 'BG000'}, {'value': '32.60', 'spread': '7.43', 'groupId': 'BG001'}, {'value': '32.51', 'spread': '8.16', 'groupId': 'BG002'}, {'value': '32.42', 'spread': '7.03', 'groupId': 'BG003'}, {'value': '32.35', 'spread': '7.55', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. Number of participants evaluable=184,184,181,186.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Multidimensional Assessment of Fatigue (MAF)', 'classes': [{'categories': [{'measurements': [{'value': '34.89', 'spread': '7.52', 'groupId': 'BG000'}, {'value': '34.97', 'spread': '7.71', 'groupId': 'BG001'}, {'value': '33.98', 'spread': '8.29', 'groupId': 'BG002'}, {'value': '34.87', 'spread': '7.70', 'groupId': 'BG003'}, {'value': '34.68', 'spread': '7.80', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue). Number of participants evaluable=183,176,175,181.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression Scale (HADS)', 'classes': [{'title': 'HADS Anxiety (HADS-A) Total', 'categories': [{'measurements': [{'value': '8.95', 'spread': '4.52', 'groupId': 'BG000'}, {'value': '8.96', 'spread': '4.50', 'groupId': 'BG001'}, {'value': '8.75', 'spread': '4.44', 'groupId': 'BG002'}, {'value': '8.85', 'spread': '4.58', 'groupId': 'BG003'}, {'value': '8.88', 'spread': '4.51', 'groupId': 'BG004'}]}]}, {'title': 'HADS Depression (HADS-D) Total', 'categories': [{'measurements': [{'value': '7.83', 'spread': '4.17', 'groupId': 'BG000'}, {'value': '7.16', 'spread': '4.03', 'groupId': 'BG001'}, {'value': '7.66', 'spread': '4.32', 'groupId': 'BG002'}, {'value': '7.39', 'spread': '4.28', 'groupId': 'BG003'}, {'value': '7.51', 'spread': '4.20', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Number of participants evaluable=182,181,176,185.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain Visual Analogue Scale (VAS) Scores', 'classes': [{'categories': [{'measurements': [{'value': '72.72', 'spread': '14.09', 'groupId': 'BG000'}, {'value': '72.43', 'spread': '13.61', 'groupId': 'BG001'}, {'value': '70.92', 'spread': '13.69', 'groupId': 'BG002'}, {'value': '71.43', 'spread': '13.51', 'groupId': 'BG003'}, {'value': '71.88', 'spread': '13.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain. Number of participants evaluable=184,184,181,186.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 747}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2006-06-02', 'resultsFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2006-06-02', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-26', 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)', 'timeFrame': 'Baseline, Week 14', 'description': 'Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Week 14', 'description': "Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)', 'timeFrame': 'Baseline, Week 14', 'description': 'Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.'}, {'measure': 'Change From Baseline in Weekly Mean Sleep Quality Score', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14', 'description': 'Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.'}, {'measure': 'Percentage of Participants With Optimal Sleep Assessed Using MOS-SS', 'timeFrame': 'Baseline, Week 14', 'description': 'Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\\*100);total score range:0-100,higher score=more disturbance.'}, {'measure': 'Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\\*100);total score range:0-100,higher score=more intensity of attribute.'}, {'measure': 'Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.'}, {'measure': 'Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.'}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.'}, {'measure': 'Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).'}, {'measure': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.'}, {'measure': 'Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14', 'timeFrame': 'Baseline, Week 14', 'description': 'Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.'}, {'measure': 'Total Daily Acetaminophen Dose', 'timeFrame': 'Week 14', 'description': 'Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '26694975', 'type': 'DERIVED', 'citation': 'Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.'}, {'pmid': '21965636', 'type': 'DERIVED', 'citation': 'Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, Leon T, Zeiher B; A0081100 Investigators. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol. 2011 Dec;38(12):2643-52. doi: 10.3899/jrheum.110569. Epub 2011 Oct 1.'}, {'pmid': '21639874', 'type': 'DERIVED', 'citation': 'Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.'}, {'pmid': '21039311', 'type': 'DERIVED', 'citation': 'Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.'}, {'pmid': '20584327', 'type': 'DERIVED', 'citation': 'Bennett RM, Russell J, Cappelleri JC, Bushmakin AG, Zlateva G, Sadosky A. Identification of symptom and functional domains that fibromyalgia patients would like to see improved: a cluster analysis. BMC Musculoskelet Disord. 2010 Jun 28;11:134. doi: 10.1186/1471-2474-11-134.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081100&StudyName=Randomized%2C%20Double-Blind%2C%20Placebo-Controlled%20Trial%20Of%20Pregabalin%20%20In%20Patients%20With%20Fibromyalgia.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACR criteria for fibromyalgia\n* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries\n\nExclusion Criteria:\n\n* Patients with other severe pain conditions\n* Patients with severe depression\n* Patients taking excluded medications'}, 'identificationModule': {'nctId': 'NCT00333866', 'briefTitle': 'Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.', 'orgStudyIdInfo': {'id': 'A0081100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: pregabalin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: pregabalin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'pregabalin', 'type': 'DRUG', 'description': '600mg/day', 'armGroupLabels': ['1']}, {'name': 'pregabalin', 'type': 'DRUG', 'description': '450mg/day', 'armGroupLabels': ['2']}, {'name': 'pregabalin', 'type': 'DRUG', 'description': '300mg/day', 'armGroupLabels': ['3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2502', 'city': 'Warrawong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.485, 'lon': 150.88833}}, {'zip': '4558', 'city': 'Maroochydore', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -26.66008, 'lon': 153.09953}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': 'V1Y 2H4', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2A 4X7', 'city': 'Bathurst', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.61814, 'lon': -65.65112}}, {'zip': 'A1B 3E1', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'K6A 1A1', 'city': 'Hawkesbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.60009, 'lon': -74.61595}}, {'zip': 'M3K 2A7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J2B 7T1', 'city': 'Drummondville', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.88336, 'lon': -72.48241}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 3J1', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1V 3M7', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'J1H 5N4', 'city': 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