Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-04-16 @ 4:54 AM
Study NCT ID:
NCT01271933
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2011-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20)', 'description': 'The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.', 'otherNumAtRisk': 441, 'otherNumAffected': 353, 'seriousNumAtRisk': 441, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.', 'otherNumAtRisk': 63, 'otherNumAffected': 34, 'seriousNumAtRisk': 63, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.', 'otherNumAtRisk': 58, 'otherNumAffected': 27, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gingival disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Mucous stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Skin warm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Excessive granulation tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Onychalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'comment': 'Not available was due to an insufficient number of events in a given arm to calculate the upper limit.', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': 'NA'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '41'}]}]}], 'analyses': [{'pValue': '0.0186', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The p-value was calculated using log-rank test for comparing pregabalin CR with placebo', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Week 19', 'description': 'The time to loss of therapeutic response (LTR) is the time to loss of pain response (\\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.'}, {'type': 'PRIMARY', 'title': 'Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to Week 19', 'description': 'Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '2.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-2.3'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '-1.9'}]}]}], 'analyses': [{'pValue': '0.3310', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '-2.0'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '-1.9'}]}]}], 'analyses': [{'pValue': '0.9247', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.8', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Subjective Wake after Sleep Onset (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.1', 'spread': '45.90', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.4', 'spread': '50.22', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.0', 'spread': '64.57', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.5', 'spread': '62.58', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.4', 'spread': '57.37', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.8', 'spread': '59.51', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '42.35', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.0', 'spread': '43.25', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.5', 'spread': '49.01', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.6', 'spread': '49.84', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.0', 'spread': '52.32', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.9', 'spread': '47.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Subjective No.of Awakenings after Sleep (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Number of times the participant awakened', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants who awakened after sleep."}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Subjective Total Sleep Time (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Total Sleep Time (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Total Sleep Time (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Total Sleep Time (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Total Sleep Time (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Subjective Total Sleep Time (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Sleep quality (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'Sleep quality (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.43', 'groupId': 'OG000'}]}]}, {'title': 'Sleep quality (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'Sleep quality (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.79', 'groupId': 'OG000'}]}]}, {'title': 'Sleep quality (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'Sleep quality (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Subjective Wake after Sleep Onset (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.8', 'spread': '37.29', 'groupId': 'OG000'}, {'value': '-32.0', 'spread': '50.47', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.4', 'spread': '39.39', 'groupId': 'OG000'}, {'value': '-28.0', 'spread': '56.99', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.0', 'spread': '40.12', 'groupId': 'OG000'}, {'value': '-33.2', 'spread': '56.45', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.9', 'spread': '38.92', 'groupId': 'OG000'}, {'value': '-26.2', 'spread': '68.24', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.0', 'spread': '44.80', 'groupId': 'OG000'}, {'value': '-37.4', 'spread': '56.79', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.0', 'spread': '46.00', 'groupId': 'OG000'}, {'value': '-31.0', 'spread': '43.96', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.8', 'spread': '37.78', 'groupId': 'OG000'}, {'value': '-31.4', 'spread': '50.08', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.0', 'spread': '39.87', 'groupId': 'OG000'}, {'value': '-43.3', 'spread': '54.45', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.7', 'spread': '38.37', 'groupId': 'OG000'}, {'value': '-35.1', 'spread': '56.47', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.9', 'spread': '41.95', 'groupId': 'OG000'}, {'value': '-35.0', 'spread': '52.67', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.5', 'spread': '34.29', 'groupId': 'OG000'}, {'value': '-36.2', 'spread': '58.67', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-32.4', 'spread': '36.37', 'groupId': 'OG000'}, {'value': '-37.3', 'spread': '56.67', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.3', 'spread': '52.27', 'groupId': 'OG000'}, {'value': '-23.1', 'spread': '46.28', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Wake after Sleep Onset (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.5', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '11.15', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.6', 'spread': '55.67', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '41.02', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.1', 'spread': '29.70', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '42.83', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.4', 'spread': '34.03', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '50.97', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.5', 'spread': '29.40', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '43.83', 'groupId': 'OG001'}]}]}, {'title': 'Latency to Sleep Onset (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.5', 'spread': '22.40', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '47.82', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '26.04', 'groupId': 'OG000'}, {'value': '-18.8', 'spread': '40.31', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.5', 'spread': '20.79', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '36.51', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '25.58', 'groupId': 'OG000'}, {'value': '-21.8', 'spread': '44.03', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.4', 'spread': '20.25', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '42.55', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.8', 'spread': '31.85', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '42.18', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.1', 'spread': '23.09', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '49.30', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '24.52', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '46.23', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.7', 'spread': '29.38', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '50.89', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Latency to Sleep Onset (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '84.31', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '8.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Subjective No.of Awakenings after Sleep (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Subjective No.of Awakenings after Sleep (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Number of times the participant awakened', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Subjective Total Sleep Time (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Total Sleep Time (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Sleep Quality (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 14) N=48,43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Quality (Week 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Subjective Wake after Sleep Onset', 'categories': [{'measurements': [{'value': '-26.2', 'groupId': 'OG000', 'lowerLimit': '-36.6', 'upperLimit': '-15.8'}, {'value': '-20.6', 'groupId': 'OG001', 'lowerLimit': '-30.7', 'upperLimit': '-10.5'}]}]}, {'title': 'Subjective Latency to Sleep Onset', 'categories': [{'measurements': [{'value': '-10.6', 'groupId': 'OG000', 'lowerLimit': '-24.2', 'upperLimit': '3.0'}, {'value': '-11.9', 'groupId': 'OG001', 'lowerLimit': '-25.0', 'upperLimit': '1.3'}]}]}], 'analyses': [{'pValue': '0.4314', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.6', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '8.5', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.12', 'groupDescription': 'This analysis is for the domain: Subjective Wake after Sleep Onset', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '19.6', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.26', 'groupDescription': 'This analysis is for the domain: Subjective Latency to Sleep Onset', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.1'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'pValue': '0.4571', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.1', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Number of times the participant awakened', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.9'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.7'}]}]}], 'analyses': [{'pValue': '0.3779', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.4'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.9'}]}]}], 'analyses': [{'pValue': '0.2009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.1', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '-2.4'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '-1.7'}]}]}], 'analyses': [{'pValue': '0.1845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.3', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': 'Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Sleep disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.8', 'spread': '24.82', 'groupId': 'OG000'}]}]}, {'title': 'Snoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '24.94', 'groupId': 'OG000'}]}]}, {'title': 'Awakening Short of Breath/with a Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.0', 'spread': '30.59', 'groupId': 'OG000'}]}]}, {'title': 'Sleep adequacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '31.17', 'groupId': 'OG000'}]}]}, {'title': 'Somnolence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '24.87', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Problems Index I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '21.62', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Problems Index II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.9', 'spread': '20.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Sleep disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.4', 'groupId': 'OG000', 'lowerLimit': '-32.0', 'upperLimit': '-18.8'}, {'value': '-15.5', 'groupId': 'OG001', 'lowerLimit': '-21.8', 'upperLimit': '-9.1'}]}]}, {'title': 'Snoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '9.9'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-10.1', 'upperLimit': '4.3'}]}]}, {'title': 'Awakening Short of Breath/with a Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.1', 'groupId': 'OG000', 'lowerLimit': '-13.5', 'upperLimit': '-2.7'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-9.3', 'upperLimit': '-0.9'}]}]}, {'title': 'Sleep adequacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '31.9'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '24.8'}]}]}, {'title': 'Somnolence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'groupId': 'OG000', 'lowerLimit': '-17.8', 'upperLimit': '-5.9'}, {'value': '-6.6', 'groupId': 'OG001', 'lowerLimit': '-12.4', 'upperLimit': '-0.9'}]}]}, {'title': 'Sleep Problems Index I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.5', 'groupId': 'OG000', 'lowerLimit': '-25.0', 'upperLimit': '-13.9'}, {'value': '-13.7', 'groupId': 'OG001', 'lowerLimit': '-19.0', 'upperLimit': '-8.3'}]}]}, {'title': 'Sleep Problems Index II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.7', 'groupId': 'OG000', 'lowerLimit': '-25.4', 'upperLimit': '-14.0'}, {'value': '-14.0', 'groupId': 'OG001', 'lowerLimit': '-19.5', 'upperLimit': '-8.6'}]}]}], 'analyses': [{'pValue': '0.0305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.9', 'ciLowerLimit': '-18.9', 'ciUpperLimit': '1.0', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.52', 'groupDescription': 'This analysis is for the domain: Sleep disturbance', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '15.5', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.17', 'groupDescription': 'This analysis is for the domain: Snoring', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '3.5', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.71', 'groupDescription': 'This analysis is for the domain: Awakening Short of Breath or with a Headache', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '17.7', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.49', 'groupDescription': 'This analysis is for the domain: Sleep adequacy', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '2.9', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.10', 'groupDescription': 'This analysis is for the domain: Somnolence', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '1.8', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.81', 'groupDescription': 'This analysis is for the domain: Sleep Problems Index I', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '2.0', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.89', 'groupDescription': 'This analysis is for the domain: Sleep Problems Index II', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.0'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.8'}]}]}], 'analyses': [{'pValue': '0.3596', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.", 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.66', 'ciUpperLimit': '2.36', 'pValueComment': 'Nominal p-value for two-sided test.', 'groupDescription': 'Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.\n\nOdds ratio \\> 1 is in favor of Pregabalin 330 - 495 mg/day.', 'statisticalMethod': 'two-sided test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'SF-36 Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '19.89', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '27.38', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 Pain Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.7', 'spread': '22.07', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 General Health Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '17.96', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '24.35', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '28.19', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '29.40', 'groupId': 'OG000'}]}]}, {'title': 'SF-36 Mental Health Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '18.94', 'groupId': 'OG000'}]}]}, {'title': 'Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '8.75', 'groupId': 'OG000'}]}]}, {'title': 'Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '11.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'SF-36 Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '18.4'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '19.5'}]}]}, {'title': 'SF-36 Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '26.0'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '23.1'}]}]}, {'title': 'SF-36 Pain Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '26.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '22.5'}]}]}, {'title': 'SF-36 General Health Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '8.3'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '14.2'}]}]}, {'title': 'SF-36 Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '19.1'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '22.3'}]}]}, {'title': 'SF-36 Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '19.6'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '19.5'}]}]}, {'title': 'SF-36 Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '11.7'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-5.4', 'upperLimit': '9.8'}]}]}, {'title': 'SF-36 Mental Health Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '11.7'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '10.2'}]}]}, {'title': 'Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '9.4'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '9.7'}]}]}, {'title': 'Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '5.8'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.7400', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '6.8', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.10', 'groupDescription': 'This analysis is for the domain: SF-36 Physical Functioning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5938', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '12.3', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.89', 'groupDescription': 'This analysis is for the domain: SF-36 Role-Physical', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4842', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '12.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.61', 'groupDescription': 'This analysis is for the domain: SF-36 Pain Index', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0827', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '0.8', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.45', 'groupDescription': 'This analysis is for the domain: SF-36 General Health Perceptions', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4561', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-12.09', 'ciUpperLimit': '5.8', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.73', 'groupDescription': 'This analysis is for the domain: SF-36 Vitality', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '8.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.31', 'groupDescription': 'This analysis is for the domain: SF-36 Social Functioning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7636', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '12.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.41', 'groupDescription': 'This analysis is for the domain: SF-36 Role-Emotional', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '8.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.54', 'groupDescription': 'This analysis is for the domain: SF-36 Mental Health Index', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8352', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.2', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.78', 'groupDescription': 'This analysis is for the domain: Physical Component Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '4.6', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.22', 'groupDescription': 'This analysis is for the domain: Mental Component Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'HADS-A Anxiety scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.47', 'groupId': 'OG000'}]}]}, {'title': 'HADS-D Depression scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', '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 Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in HADS Score at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'HADS-A Anxiety scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '0.4'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-0.6'}]}]}, {'title': 'HADS-D Depression scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '-0.4'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'pValue': '0.1901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '2.3', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'HADS-A Anxiety scale', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6914', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.0', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.65', 'groupDescription': 'HADS-D Depression scale', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', '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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Item 1: Physical activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Item 2: Feel good', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '3.33', 'groupId': 'OG000'}]}]}, {'title': 'Item 3: Work missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.42', 'groupId': 'OG000'}]}]}, {'title': 'Item 4: Do job', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Item 5: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Item 6: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.43', 'groupId': 'OG000'}]}]}, {'title': 'Item 7: Rested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Item 8: Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Item 9: Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.95', 'groupId': 'OG000'}]}]}, {'title': 'Item 10: Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '16.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in FIQ Score at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Item 1: Physical activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-0.4'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-0.8'}]}]}, {'title': 'Item 2: feel good', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '-2.1'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '-2.3'}]}]}, {'title': 'Item 3: Work missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.7'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-0.5'}]}]}, {'title': 'Item 4: Do job', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-1.3'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-1.4'}]}]}, {'title': 'Item 5: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '-2.0'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-1.5'}]}]}, {'title': 'Item 6: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-1.6'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-1.7'}]}]}, {'title': 'Item 7: Rested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '-1.8'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-1.4'}]}]}, {'title': 'Item 8: Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '-1.6'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-1.4'}]}]}, {'title': 'Item 9: Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '-1.0'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '-0.9'}]}]}, {'title': 'Item 10: Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.0'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.0'}]}]}, {'title': 'Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.6', 'groupId': 'OG000', 'lowerLimit': '-25.3', 'upperLimit': '-13.9'}, {'value': '-19.1', 'groupId': 'OG001', 'lowerLimit': '-24.6', 'upperLimit': '-13.7'}]}]}], 'analyses': [{'pValue': '0.3721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.2', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'This analysis is for the domain: Item 1: Physical activities', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'groupDescription': 'This analysis is for the domain: Item 2: Feel good', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.5', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'This analysis is for the domain: Item 3: Work missed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8824', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.2', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'This analysis is for the domain: Item 4: Do job', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2742', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'This analysis is for the domain: Item 5: Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8520', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.0', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'This analysis is for the domain: Item 6: Fatigue', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.7', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'groupDescription': 'This analysis is for the domain: Item 7: Rested', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.9', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'groupDescription': 'This analysis is for the domain: Item 8: Stiffness', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8937', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.0', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'This analysis is for the domain: Item 9: Anxiety', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.9', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'This analysis is for the domain: Item 10: Depression', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '7.3', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.91', 'groupDescription': 'This analysis is for the total score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': 'The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'General fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': 'Physical fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Reduced activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Reduced motivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': 'Mental fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in MFI Score at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'General fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.6'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.3'}]}]}, {'title': 'Physical fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.5'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.7'}]}]}, {'title': 'Reduced activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.6'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.2'}]}]}, {'title': 'Reduced motivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.5'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.8'}]}]}, {'title': 'Mental fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.4606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.9', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'This analysis is for the domain: General Fatigue', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.5', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'groupDescription': 'This analysis is for the domain: Physical Fatigue', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.0', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'This analysis is for the domain: Reduced activity', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0695', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.3', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'This analysis is for the domain: Reduced motivation', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5869', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'This analysis is for the domain: Mental fatigue', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': 'The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Benefit from treatment-No', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Benefit from treatment-Little benefit', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}]}]}, {'title': 'Benefit from treatment-much benefit', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction from treatment-very dissatisfied', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction from treatment-a little dissatisfied', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction from treatment-a little satisfied', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction from treatment-very satisfied', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}]}]}, {'title': 'Willing to continue treatment-very unwilling', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Willing to continue treatment-little unwilling', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Willing to continue treatment-little bit willing', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Willing to continue treatment-very willing', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Benefit from treatment-No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Benefit from treatment-Little benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Benefit from treatment-much benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction from treatment-very dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction from treatment-a little dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction from treatment-a little satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction from treatment-very satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Willing to continue treatment-very unwilling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Willing to continue treatment-little unwilling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Willing to continue treatment-little bit willing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Willing to continue treatment-very willing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0296', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.29', 'ciLowerLimit': '1.09', 'ciUpperLimit': '4.81', 'pValueComment': 'Nominal p-value for two-sided test.', 'groupDescription': 'This analysis is for the domain: Benefit from treatment', 'statisticalMethod': 'two-sided test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4691', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.64', 'ciUpperLimit': '2.61', 'pValueComment': 'Nominal p-value for two-sided test', 'groupDescription': 'This analysis is for the domain: Satisfaction from treatment', 'statisticalMethod': 'two-sided test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.01', 'pValueComment': 'Nominal p-value for two-sided test', 'groupDescription': 'This analysis is for the domain: Willingness to continue treatment', 'statisticalMethod': 'two-sided test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19', 'description': "The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed"= participants evaluable for specified categories.'}, {'type': 'SECONDARY', 'title': 'Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Percent Work Time Missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '48.69', 'groupId': 'OG000'}]}]}, {'title': 'Percent Impairment While Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '31.29', 'groupId': 'OG000'}]}]}, {'title': 'Percent Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'spread': '25.88', 'groupId': 'OG000'}]}]}, {'title': 'Percent Overall Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.3', 'spread': '27.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Percent Work Time Missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'groupId': 'OG000', 'lowerLimit': '-21.3', 'upperLimit': '6.7'}, {'value': '-26.7', 'groupId': 'OG001', 'lowerLimit': '-41.0', 'upperLimit': '-12.3'}]}]}, {'title': 'Percent Impairment While Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'groupId': 'OG000', 'lowerLimit': '-19.7', 'upperLimit': '-8.2'}, {'value': '-15.0', 'groupId': 'OG001', 'lowerLimit': '-20.8', 'upperLimit': '-9.3'}]}]}, {'title': 'Percent Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.4', 'groupId': 'OG000', 'lowerLimit': '-19.0', 'upperLimit': '-13.7'}, {'value': '-19.6', 'groupId': 'OG001', 'lowerLimit': '-22.1', 'upperLimit': '-17.0'}]}]}, {'title': 'Percent Overall Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.9', 'groupId': 'OG000', 'lowerLimit': '-18.7', 'upperLimit': '-13.1'}, {'value': '-17.5', 'groupId': 'OG001', 'lowerLimit': '-20.2', 'upperLimit': '-14.8'}]}]}], 'analyses': [{'pValue': '0.0562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '39.2', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.85', 'groupDescription': 'This analysis is for the domain: Percent Work Time Missed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '9.2', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.96', 'groupDescription': 'This analysis is for the domain: Percent Impairment While Working', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0819', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '6.8', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.82', 'groupDescription': 'This analysis is for the domain: Percent Activity Impairment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4135', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '5.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.91', 'groupDescription': 'This analysis is for the domain: Percent Overall Work Impairment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 19', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Total Sleep Time (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Total Sleep Time (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Total Sleep Time (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Total Sleep Time (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Total Sleep Time (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Minutes of Interrupted Sleep (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '12.63', 'groupId': 'OG000'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '16.10', 'groupId': 'OG000'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '15.66', 'groupId': 'OG000'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '16.12', 'groupId': 'OG000'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '19.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Sleep Fragmentation Index (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '5.27', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Fragmentation Index (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '5.45', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Fragmentation Index (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '5.27', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Fragmentation Index (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.63', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Fragmentation Index (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.', 'unitOfMeasure': 'Percentage of immobile bouts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Total daytime activity (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10264.3', 'spread': '90090.07', 'groupId': 'OG000'}]}]}, {'title': 'Total daytime activity (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10588.1', 'spread': '59150.38', 'groupId': 'OG000'}]}]}, {'title': 'Total daytime activity (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8635.8', 'spread': '54823.64', 'groupId': 'OG000'}]}]}, {'title': 'Total daytime activity (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7134.2', 'spread': '58221.22', 'groupId': 'OG000'}]}]}, {'title': 'Total daytime activity (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18420.7', 'spread': '61725.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.', 'unitOfMeasure': 'Counts of total daytime activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'classes': [{'title': 'Percent Sedentary (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '6.66', 'groupId': 'OG000'}]}]}, {'title': 'Percent Sedentary (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.61', 'groupId': 'OG000'}]}]}, {'title': 'Percent Sedentary (Week 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '5.62', 'groupId': 'OG000'}]}]}, {'title': 'Percent Sedentary (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '6.07', 'groupId': 'OG000'}]}]}, {'title': 'Percent Sedentary (Week 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '5.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.', 'unitOfMeasure': 'Percent of daytime', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Total Sleep Time (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Total Sleep Time (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Total Sleep Time (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Total Sleep Time (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Total Sleep Time (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Minutes of Interrupted Sleep (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '10.27', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '18.97', 'groupId': 'OG001'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '14.77', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '14.10', 'groupId': 'OG001'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '20.33', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '14.14', 'groupId': 'OG001'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '19.12', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '13.19', 'groupId': 'OG001'}]}]}, {'title': 'Minutes of Interrupted Sleep (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '25.03', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '13.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Sleep Fragmentation Index (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '5.53', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '5.17', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Fragmentation Index (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '6.29', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Fragmentation Index (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '7.28', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '5.23', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Fragmentation Index (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Fragmentation Index (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '5.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.', 'unitOfMeasure': 'Percentage of immobile bouts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Total daytime activity (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1894.1', 'spread': '46879.81', 'groupId': 'OG000'}, {'value': '-2083.9', 'spread': '40939.67', 'groupId': 'OG001'}]}]}, {'title': 'Total daytime activity ((Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.7', 'spread': '50114.87', 'groupId': 'OG000'}, {'value': '-6691.1', 'spread': '47353.03', 'groupId': 'OG001'}]}]}, {'title': 'Total daytime activity ((Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4362.4', 'spread': '51922.75', 'groupId': 'OG000'}, {'value': '521.8', 'spread': '46996.71', 'groupId': 'OG001'}]}]}, {'title': 'Total daytime activity ((Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-179.7', 'spread': '55858.35', 'groupId': 'OG000'}, {'value': '-4523.8', 'spread': '52629.95', 'groupId': 'OG001'}]}]}, {'title': 'Total daytime activity ((Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4138.3', 'spread': '54924.02', 'groupId': 'OG000'}, {'value': '-4649.4', 'spread': '58121.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.', 'unitOfMeasure': 'Counts of total daytime activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Percent Sedentary (Week 11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '6.69', 'groupId': 'OG001'}]}]}, {'title': 'Percent Sedentary (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Percent Sedentary (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Percent Sedentary (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '6.56', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '7.27', 'groupId': 'OG001'}]}]}, {'title': 'Percent Sedentary (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '6.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.', 'unitOfMeasure': 'Percent of daytime', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.9'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '0.1224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.9', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '2.9'}, {'value': '-2.3', 'groupId': 'OG001', 'lowerLimit': '-8.8', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.7680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '6.9', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '-0.5'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.1360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '0.6', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.', 'unitOfMeasure': 'Percentage of immobile bouts', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-182.7', 'groupId': 'OG000', 'lowerLimit': '-20143.1', 'upperLimit': '19777.7'}, {'value': '-6672.2', 'groupId': 'OG001', 'lowerLimit': '-26663.5', 'upperLimit': '13319.1'}]}]}], 'analyses': [{'pValue': '0.6077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6489.5', 'ciLowerLimit': '-18648.6', 'ciUpperLimit': '31627.6', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12579.50', 'groupDescription': 'This analysis is for the domain: Total daytime activity', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.', 'unitOfMeasure': 'Counts of total daytime activity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG001', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '0.8'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.6647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '3.4', 'pValueComment': 'Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.', 'unitOfMeasure': 'Percent of daytime', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}, {'id': 'OG001', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'OG002', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 7 and Week 11 to Week 20', 'description': 'C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 \\[not at all\\] to 4 \\[extremely\\]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population in the single and double blind phase consisted of all paticipants who received at least 1 dose of study medication and who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}, {'id': 'FG001', 'title': 'Pregabalin (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}, {'id': 'FG002', 'title': 'Placebo (Double Blind Phase)', 'description': 'At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.'}], 'periods': [{'title': 'Single-Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '441'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '(Failed to meet dosing requirement)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '(Protocol non-compliance)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '(Participant request-personal reason)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind Phase', 'milestones': [{'type': 'STARTED', 'comment': '198 participants completed SB phase but not randomized in DB phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant request-personal reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was performed in 4 countries at 50 centers.', 'preAssignmentDetails': 'Baseline phase was from Visit 1 to Visit 2. Eligible participants entered single blind (SB) phase (Visit 2 to Visit 6) \\[6 weeks\\]. Responders with at least 50% improvement in pain from baseline at the end of SB phase were considered for double blind (DB) phase (Visit 6 to Visit 9) \\[13 weeks\\]. All subjects entered 1 week taper phase after completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin (Single Blind Phase)', 'description': 'Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \\[Week 1\\], Visit 4 \\[Week 2\\], and Visit 5 \\[Week 3\\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '18 - 44 years', 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}]}]}, {'title': '45 - 64 years', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '392', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2013-08-30', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2011-01-05', 'dispFirstSubmitQcDate': '2013-08-30', 'resultsFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2011-01-05', 'dispFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-14', 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).'}, {'measure': 'Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7', 'timeFrame': 'Baseline, Weeks 3, 4, 5, 6 and 7', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15', 'timeFrame': 'Baseline, Weeks 11, 12, 13, 14 and 15', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.'}, {'measure': 'Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)', 'timeFrame': 'Week 1 to Week 7 and Week 11 to Week 20', 'description': 'C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 \\[not at all\\] to 4 \\[extremely\\]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm.'}], 'primaryOutcomes': [{'measure': 'Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)', 'timeFrame': 'Randomization to Week 19', 'description': 'The time to loss of therapeutic response (LTR) is the time to loss of pain response (\\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).'}, {'measure': 'Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event', 'timeFrame': 'Randomization to Week 19', 'description': 'Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.'}], 'secondaryOutcomes': [{'measure': 'Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).'}, {'measure': 'Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'timeFrame': 'Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit', 'timeFrame': 'Baseline, Double blind endpoint visit (Week 19)', 'description': 'The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent).'}, {'measure': 'Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)', 'timeFrame': 'Baseline, Week 6', 'description': 'Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)', 'timeFrame': 'Baseline, Week 19', 'description': 'Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II', 'timeFrame': 'Baseline, Week 6', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep."}, {'measure': 'Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep', 'timeFrame': 'Baseline, Week 6', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep."}, {'measure': 'Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II', 'timeFrame': 'Baseline, Week 19', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep."}, {'measure': 'Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep', 'timeFrame': 'Baseline, Week 19', 'description': "The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep."}, {'measure': 'Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6', 'timeFrame': 'Week 6', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19', 'timeFrame': 'Week 19', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.'}, {'measure': 'Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19', 'timeFrame': 'Baseline, Week 19', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6', 'timeFrame': 'Baseline, Week 6', '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': 'Double-Blind Phase: Change From Baseline in HADS Score at Week 19', 'timeFrame': 'Baseline, Week 19', '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': 'Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.'}, {'measure': 'Double-Blind Phase: Change From Baseline in FIQ Score at Week 19', 'timeFrame': 'Baseline, Week 19', 'description': 'The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.'}, {'measure': 'Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.'}, {'measure': 'Double-Blind Phase: Change From Baseline in MFI Score at Week 19', 'timeFrame': 'Baseline, Week 19', 'description': 'The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.'}, {'measure': 'Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6', 'timeFrame': 'Week 6', 'description': "The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy."}, {'measure': 'Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19', 'timeFrame': 'Week 19', 'description': "The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy."}, {'measure': 'Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.'}, {'measure': 'Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19', 'timeFrame': 'Baseline, Week 19', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.'}, {'measure': 'Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)', 'timeFrame': 'Baseline, Double blind end point visit (Week 19)', 'description': 'Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'pain', 'pregabalin', 'Lyrica'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '24867298', 'type': 'DERIVED', 'citation': 'Arnold LM, Arsenault P, Huffman C, Patrick JL, Messig M, Chew ML, Sanin L, Scavone JM, Pauer L, Clair AG. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin. 2014 Oct;30(10):2069-83. doi: 10.1185/03007995.2014.928275. Epub 2014 Jun 27.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081245&StudyName=Study%20Of%20A%20Controlled%20Release%20Formulation%20Of%20Pregabalin%20In%20Fibromyalgia%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have fibromyalgia.\n\nExclusion Criteria:\n\n* Patients with other painful conditions cannot participate.'}, 'identificationModule': {'nctId': 'NCT01271933', 'briefTitle': 'Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)', 'orgStudyIdInfo': {'id': 'A0081245'}, 'secondaryIdInfos': [{'id': 'FIBROMYALGIA', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin', 'interventionNames': ['Drug: pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'pregabalin', 'type': 'DRUG', 'description': 'controlled release tablet; 165-495 mg/day; given once daily', 'armGroupLabels': ['Pregabalin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'matching placebo tablet; given once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Andrew O. 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