Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT00386334
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2006-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-866-503-6351', 'title': 'Lunesta Medical Director', 'organization': 'Sepracor Inc.'}, 'certainAgreement': {'otherDetails': 'In addition to the \\<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The data gathered was subjective (except for actigraphy endpoints) and relied either on self reporting or patient assessments derived from standardized questionnaires.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablets', 'otherNumAffected': 61, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets', 'otherNumAffected': 86, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 10.1'}, {'term': 'Stomach Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA10.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA10.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA10.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA10.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 45, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 51, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 35, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cholecystisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Stress Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '33.18', 'spread': '50.02', 'groupId': 'OG000'}, {'value': '63.24', 'spread': '52.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose)-12 weeks', 'description': 'The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=191,190)', 'categories': [{'measurements': [{'value': '20.65', 'spread': '42.34', 'groupId': 'OG000', 'lowerLimit': '13.68', 'upperLimit': '25.72'}, {'value': '51.02', 'spread': '46.43', 'groupId': 'OG001', 'lowerLimit': '44.88', 'upperLimit': '56.99'}]}]}, {'title': 'Week 6 (n=191,191)', 'categories': [{'measurements': [{'value': '32.47', 'spread': '53.31', 'groupId': 'OG000', 'lowerLimit': '25.29', 'upperLimit': '39.67'}, {'value': '61.91', 'spread': '54.15', 'groupId': 'OG001', 'lowerLimit': '56.18', 'upperLimit': '70.63'}]}]}, {'title': 'Week 9 (n=191,191)', 'categories': [{'measurements': [{'value': '38.73', 'spread': '57.73', 'groupId': 'OG000', 'lowerLimit': '30.99', 'upperLimit': '46.75'}, {'value': '69.00', 'spread': '61.58', 'groupId': 'OG001', 'lowerLimit': '63.00', 'upperLimit': '78.83'}]}]}, {'title': 'Week 12 (n=191,191)', 'categories': [{'measurements': [{'value': '40.86', 'spread': '60.74', 'groupId': 'OG000', 'lowerLimit': '33.16', 'upperLimit': '49.63'}, {'value': '70.97', 'spread': '62.18', 'groupId': 'OG001', 'lowerLimit': '64.95', 'upperLimit': '81.50'}]}]}, {'title': 'Week 14 (n=191,191)', 'categories': [{'measurements': [{'value': '42.78', 'spread': '66.52', 'groupId': 'OG000', 'lowerLimit': '35.54', 'upperLimit': '53.54'}, {'value': '50.12', 'spread': '68.25', 'groupId': 'OG001', 'lowerLimit': '44.83', 'upperLimit': '62.92'}]}]}, {'title': 'Week 16 (n=191,191)', 'categories': [{'measurements': [{'value': '37.43', 'spread': '67.68', 'groupId': 'OG000', 'lowerLimit': '31.36', 'upperLimit': '49.07'}, {'value': '47.17', 'spread': '63.68', 'groupId': 'OG001', 'lowerLimit': '42.89', 'upperLimit': '60.69'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 3, 6, 9, 12, 14, 16', 'description': 'The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,191)', 'categories': [{'measurements': [{'value': '294.03', 'spread': '63.30', 'groupId': 'OG000'}, {'value': '297.86', 'spread': '56.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=192,192)', 'categories': [{'measurements': [{'value': '314.53', 'spread': '63.52', 'groupId': 'OG000'}, {'value': '347.37', 'spread': '57.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=192,193)', 'categories': [{'measurements': [{'value': '326.25', 'spread': '65.41', 'groupId': 'OG000'}, {'value': '358.72', 'spread': '61.47', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=192,193)', 'categories': [{'measurements': [{'value': '332.47', 'spread': '65.25', 'groupId': 'OG000'}, {'value': '365.80', 'spread': '64.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=192,193)', 'categories': [{'measurements': [{'value': '334.69', 'spread': '69.91', 'groupId': 'OG000'}, {'value': '367.75', 'spread': '66.08', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=192,193)', 'categories': [{'measurements': [{'value': '326.98', 'spread': '62.88', 'groupId': 'OG000'}, {'value': '360.08', 'spread': '59.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=192,193)', 'categories': [{'measurements': [{'value': '336.55', 'spread': '71.13', 'groupId': 'OG000'}, {'value': '347.12', 'spread': '72.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=192,193)', 'categories': [{'measurements': [{'value': '331.29', 'spread': '72.53', 'groupId': 'OG000'}, {'value': '344.20', 'spread': '74.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 3, 6, 9, 12, 14, 16', 'description': 'The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.92', 'spread': '46.99', 'groupId': 'OG000'}, {'value': '-24.62', 'spread': '46.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - Week12', 'description': 'Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=191,190)', 'categories': [{'measurements': [{'value': '-13.34', 'spread': '41.97', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.90'}, {'value': '-21.89', 'spread': '44.38', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.74'}]}]}, {'title': 'Week 6 (n=191,191)', 'categories': [{'measurements': [{'value': '-19.69', 'spread': '52.08', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '0.83'}, {'value': '-24.13', 'spread': '49.20', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '0.70'}]}]}, {'title': 'Week 9 (n=191,191)', 'categories': [{'measurements': [{'value': '-23.02', 'spread': '50.75', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.79'}, {'value': '-24.21', 'spread': '52.62', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.68'}]}]}, {'title': 'Week 12 (n=191,191)', 'categories': [{'measurements': [{'value': '-23.54', 'spread': '54.14', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.78'}, {'value': '-28.35', 'spread': '49.72', 'groupId': 'OG001', 'lowerLimit': '0.53', 'upperLimit': '0.64'}]}]}, {'title': 'Week 14 (n=191,191)', 'categories': [{'measurements': [{'value': '-25.08', 'spread': '58.99', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.75'}, {'value': '-17.00', 'spread': '55.55', 'groupId': 'OG001', 'lowerLimit': '0.62', 'upperLimit': '0.77'}]}]}, {'title': 'Week 16 (n=191,191)', 'categories': [{'measurements': [{'value': '-24.61', 'spread': '55.22', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.76'}, {'value': '-18.73', 'spread': '51.67', 'groupId': 'OG001', 'lowerLimit': '0.60', 'upperLimit': '0.74'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Sleep Latency Reported at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,191)', 'categories': [{'measurements': [{'value': '82.17', 'spread': '74.08', 'groupId': 'OG000'}, {'value': '75.68', 'spread': '56.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=192,192)', 'categories': [{'measurements': [{'value': '68.80', 'spread': '64.51', 'groupId': 'OG000'}, {'value': '54.69', 'spread': '46.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=192,193)', 'categories': [{'measurements': [{'value': '62.57', 'spread': '60.06', 'groupId': 'OG000'}, {'value': '52.11', 'spread': '48.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=192,193)', 'categories': [{'measurements': [{'value': '59.23', 'spread': '52.05', 'groupId': 'OG000'}, {'value': '51.75', 'spread': '51.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=192,193)', 'categories': [{'measurements': [{'value': '58.69', 'spread': '51.84', 'groupId': 'OG000'}, {'value': '47.66', 'spread': '39.70', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=192,193)', 'categories': [{'measurements': [{'value': '62.32', 'spread': '54.82', 'groupId': 'OG000'}, {'value': '51.51', 'spread': '43.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=192,193)', 'categories': [{'measurements': [{'value': '57.23', 'spread': '49.94', 'groupId': 'OG000'}, {'value': '58.89', 'spread': '45.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=192,193)', 'categories': [{'measurements': [{'value': '57.62', 'spread': '51.99', 'groupId': 'OG000'}, {'value': '57.17', 'spread': '45.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.75', 'spread': '38.45', 'groupId': 'OG000'}, {'value': '-36.40', 'spread': '41.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) -week 12', 'description': 'Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=188,190)', 'categories': [{'measurements': [{'value': '-8.55', 'spread': '35.80', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.93'}, {'value': '-29.26', 'spread': '37.68', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '0.61'}]}]}, {'title': 'Week 6 (n=189,191)', 'categories': [{'measurements': [{'value': '-13.46', 'spread': '39.01', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '0.86'}, {'value': '-36.57', 'spread': '43.11', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.51'}]}]}, {'title': 'Week 9 (n=189,191)', 'categories': [{'measurements': [{'value': '-17.67', 'spread': '44.13', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.77'}, {'value': '-40.32', 'spread': '45.12', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.49'}]}]}, {'title': 'Week 12 (n=189,191)', 'categories': [{'measurements': [{'value': '-19.13', 'spread': '43.39', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.74'}, {'value': '-39.61', 'spread': '46.48', 'groupId': 'OG001', 'lowerLimit': '0.35', 'upperLimit': '0.48'}]}]}, {'title': 'Week 14 (n=189,191)', 'categories': [{'measurements': [{'value': '-22.72', 'spread': '45.00', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.64'}, {'value': '-32.27', 'spread': '47.55', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.55'}]}]}, {'title': 'Week 16 (n=189,191)', 'categories': [{'measurements': [{'value': '-20.18', 'spread': '48.06', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '0.64'}, {'value': '-31.13', 'spread': '51.35', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), weeks 3,6,9,12,14,16', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=190,191)', 'categories': [{'measurements': [{'value': '90.86', 'spread': '51.77', 'groupId': 'OG000'}, {'value': '92.66', 'spread': '58.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,192)', 'categories': [{'measurements': [{'value': '83.17', 'spread': '49.63', 'groupId': 'OG000'}, {'value': '64.33', 'spread': '45.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=192,193)', 'categories': [{'measurements': [{'value': '77.86', 'spread': '48.82', 'groupId': 'OG000'}, {'value': '56.49', 'spread': '44.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=192,193)', 'categories': [{'measurements': [{'value': '73.33', 'spread': '49.71', 'groupId': 'OG000'}, {'value': '52.75', 'spread': '42.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=192,193)', 'categories': [{'measurements': [{'value': '72.02', 'spread': '50.44', 'groupId': 'OG000'}, {'value': '53.45', 'spread': '44.23', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=192,193)', 'categories': [{'measurements': [{'value': '76.59', 'spread': '47.52', 'groupId': 'OG000'}, {'value': '56.68', 'spread': '42.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=192,193)', 'categories': [{'measurements': [{'value': '68.39', 'spread': '51.87', 'groupId': 'OG000'}, {'value': '60.71', 'spread': '47.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=192,193)', 'categories': [{'measurements': [{'value': '71.27', 'spread': '54.61', 'groupId': 'OG000'}, {'value': '61.84', 'spread': '48.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - Week12', 'description': 'The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=188,190)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '.63', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '-0.10'}, {'value': '-0.46', 'spread': '0.70', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '-0.34'}]}]}, {'title': 'Week 6 (n=189,191)', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.77', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '-0.17'}, {'value': '-0.56', 'spread': '0.83', 'groupId': 'OG001', 'lowerLimit': '-0.64', 'upperLimit': '-0.44'}]}]}, {'title': 'Week 9 (n=189,191)', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.81', 'groupId': 'OG000', 'lowerLimit': '-0.47', 'upperLimit': '-0.26'}, {'value': '-0.57', 'spread': '0.88', 'groupId': 'OG001', 'lowerLimit': '-0.66', 'upperLimit': '-0.45'}]}]}, {'title': 'Week 12 (n=189,191)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.83', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '-0.28'}, {'value': '-0.65', 'spread': '0.90', 'groupId': 'OG001', 'lowerLimit': '-0.75', 'upperLimit': '-0.52'}]}]}, {'title': 'Week 14 (n=189,191)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.85', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '-0.30'}, {'value': '-0.46', 'spread': '0.96', 'groupId': 'OG001', 'lowerLimit': '-0.57', 'upperLimit': '-0.33'}]}]}, {'title': 'Week 16 (n=189,191)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.87', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '-0.29'}, {'value': '-0.44', 'spread': '0.97', 'groupId': 'OG001', 'lowerLimit': '-0.57', 'upperLimit': '-0.33'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Awakenings (Subject-reported) at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=190,191)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,192)', 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=192,193)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=192,193)', 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=192,193)', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=192,193)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=192,193)', 'categories': [{'measurements': [{'value': '1.58', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=192,193)', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - Week12', 'description': 'Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=188,190)', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.52'}, {'value': '1.12', 'spread': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.94', 'upperLimit': '1.22'}]}]}, {'title': 'Week 6 (n=189,191)', 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.83'}, {'value': '1.35', 'spread': '1.43', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '1.50'}]}]}, {'title': 'Week 9 (n=189,191)', 'categories': [{'measurements': [{'value': '0.81', 'spread': '1.58', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.06'}, {'value': '1.52', 'spread': '1.62', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '1.69'}]}]}, {'title': 'Week 12 (n=189,191)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '1.77', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.19'}, {'value': '1.57', 'spread': '1.73', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '1.76'}]}]}, {'title': 'Week 14 (n=189,191)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '1.88', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.34'}, {'value': '1.26', 'spread': '2.07', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.48'}]}]}, {'title': 'Week 16 (n=189, 191)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.96', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.23'}, {'value': '1.22', 'spread': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=190,191)', 'categories': [{'measurements': [{'value': '4.84', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,190)', 'categories': [{'measurements': [{'value': '5.22', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=192,193)', 'categories': [{'measurements': [{'value': '5.48', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '6.01', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=192,193)', 'categories': [{'measurements': [{'value': '5.67', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=192,193)', 'categories': [{'measurements': [{'value': '5.78', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '6.22', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=192, 193)', 'categories': [{'measurements': [{'value': '5.54', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '6.04', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=192,193)', 'categories': [{'measurements': [{'value': '5.88', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=192,193)', 'categories': [{'measurements': [{'value': '5.73', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 0,3,6,9,12,14,16', 'description': 'Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=188, 190)', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=189, 191)', 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=189, 191)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=189, 191)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=189,191)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=189,191)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Depth of Sleep at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=190,191)', 'categories': [{'measurements': [{'value': '4.87', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '4.72', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,192)', 'categories': [{'measurements': [{'value': '5.29', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=192,193)', 'categories': [{'measurements': [{'value': '5.51', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=192,193)', 'categories': [{'measurements': [{'value': '5.71', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '6.15', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=192, 193)', 'categories': [{'measurements': [{'value': '5.82', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '6.18', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=192,193)', 'categories': [{'measurements': [{'value': '5.58', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=192,193)', 'categories': [{'measurements': [{'value': '5.89', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=192,193)', 'categories': [{'measurements': [{'value': '5.76', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '5.84', 'spread': '1.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 0,3,6,9,12,14,16', 'description': 'Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=189,191)', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=189,192)', 'categories': [{'measurements': [{'value': '0.55', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=189,192)', 'categories': [{'measurements': [{'value': '0.72', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=189,192)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=189,192)', 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=189,192)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Daytime Alertness at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,193)', 'categories': [{'measurements': [{'value': '5.34', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '5.42', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,191)', 'categories': [{'measurements': [{'value': '5.74', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '6.18', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=190,192)', 'categories': [{'measurements': [{'value': '5.89', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=190,192)', 'categories': [{'measurements': [{'value': '6.06', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '6.52', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=190,192)', 'categories': [{'measurements': [{'value': '6.13', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '6.64', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=190,192)', 'categories': [{'measurements': [{'value': '5.95', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '6.44', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=190,192)', 'categories': [{'measurements': [{'value': '6.19', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '6.47', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=190,192)', 'categories': [{'measurements': [{'value': '6.13', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '6.39', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=189,191)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=189,192)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=189,192)', 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=189,192)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=189,192)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=189,192)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Ability to Function at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,193)', 'categories': [{'measurements': [{'value': '5.62', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,191)', 'categories': [{'measurements': [{'value': '5.98', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=190,192)', 'categories': [{'measurements': [{'value': '6.09', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=190,192)', 'categories': [{'measurements': [{'value': '6.24', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=190,192)', 'categories': [{'measurements': [{'value': '6.32', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '6.79', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=190,192)', 'categories': [{'measurements': [{'value': '6.16', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '6.61', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=190,192)', 'categories': [{'measurements': [{'value': '6.38', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=190,192)', 'categories': [{'measurements': [{'value': '6.31', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) \\& average for double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseliine (week 0), Day 1 (post first dose) - week 12', 'description': 'Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=189,191)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=189,192)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=189,192)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=189,192)', 'categories': [{'measurements': [{'value': '0.66', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=189,192)', 'categories': [{'measurements': [{'value': '0.72', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=189,192)', 'categories': [{'measurements': [{'value': '0.66', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '1.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Ability to Concentrate at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,193)', 'categories': [{'measurements': [{'value': '5.66', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,191)', 'categories': [{'measurements': [{'value': '5.99', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=190,192)', 'categories': [{'measurements': [{'value': '6.10', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=190,192)', 'categories': [{'measurements': [{'value': '6.27', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=190,192)', 'categories': [{'measurements': [{'value': '6.33', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '6.77', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=190,192)', 'categories': [{'measurements': [{'value': '6.17', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '6.60', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=190,192)', 'categories': [{'measurements': [{'value': '6.39', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '6.64', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=190,192)', 'categories': [{'measurements': [{'value': '6.33', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) \\& average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=189,191)', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=189,192)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=189,192)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=189,192)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=189,192)', 'categories': [{'measurements': [{'value': '0.72', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=189,192)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-reported Physical Well-Being at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,193)', 'categories': [{'measurements': [{'value': '5.45', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '5.62', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=190,191)', 'categories': [{'measurements': [{'value': '5.80', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=190,192)', 'categories': [{'measurements': [{'value': '5.92', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=190,192)', 'categories': [{'measurements': [{'value': '6.06', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=190,192)', 'categories': [{'measurements': [{'value': '6.11', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=190,192)', 'categories': [{'measurements': [{'value': '5.97', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=190,192)', 'categories': [{'measurements': [{'value': '6.18', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '6.51', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=190,192)', 'categories': [{'measurements': [{'value': '6.09', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), \\& average for double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.78', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1175', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose)- week 12', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'number of naps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=110,92)', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=110,93)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=110, 93)', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110, 93)', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=110,93)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=110,93)', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '2.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'number of naps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=111,94)', 'categories': [{'measurements': [{'value': '4.03', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '3.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=110,92)', 'categories': [{'measurements': [{'value': '3.67', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=110,93)', 'categories': [{'measurements': [{'value': '3.26', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=110,93)', 'categories': [{'measurements': [{'value': '3.10', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110,93)', 'categories': [{'measurements': [{'value': '3.10', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=110,93)', 'categories': [{'measurements': [{'value': '3.28', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=110,93)', 'categories': [{'measurements': [{'value': '3.35', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=110,93)', 'categories': [{'measurements': [{'value': '3.14', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '3.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'number of naps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.02', 'spread': '125.59', 'groupId': 'OG000'}, {'value': '-60.06', 'spread': '156.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0717', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=110,92)', 'categories': [{'measurements': [{'value': '-21.66', 'spread': '116.53', 'groupId': 'OG000'}, {'value': '-59.06', 'spread': '158.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=110,93)', 'categories': [{'measurements': [{'value': '-40.02', 'spread': '140.47', 'groupId': 'OG000'}, {'value': '-65.99', 'spread': '163.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=110,93)', 'categories': [{'measurements': [{'value': '-40.25', 'spread': '146.42', 'groupId': 'OG000'}, {'value': '-56.59', 'spread': '184.47', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110,93)', 'categories': [{'measurements': [{'value': '-42.15', 'spread': '136.85', 'groupId': 'OG000'}, {'value': '-58.22', 'spread': '163.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=110,93)', 'categories': [{'measurements': [{'value': '-27.28', 'spread': '142.36', 'groupId': 'OG000'}, {'value': '-44.48', 'spread': '165.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=110,93)', 'categories': [{'measurements': [{'value': '-38.14', 'spread': '137.69', 'groupId': 'OG000'}, {'value': '-49.15', 'spread': '202.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-Reported Total Nap Time at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=111,94)', 'categories': [{'measurements': [{'value': '189.31', 'spread': '262.08', 'groupId': 'OG000'}, {'value': '171.62', 'spread': '237.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=110,92)', 'categories': [{'measurements': [{'value': '169.24', 'spread': '253.66', 'groupId': 'OG000'}, {'value': '114.43', 'spread': '151.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=110,93)', 'categories': [{'measurements': [{'value': '150.88', 'spread': '226.90', 'groupId': 'OG000'}, {'value': '106.99', 'spread': '133.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=110,93)', 'categories': [{'measurements': [{'value': '150.65', 'spread': '234.11', 'groupId': 'OG000'}, {'value': '116.39', 'spread': '156.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110,93)', 'categories': [{'measurements': [{'value': '148.75', 'spread': '256.87', 'groupId': 'OG000'}, {'value': '114.76', 'spread': '149.73', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=110,93)', 'categories': [{'measurements': [{'value': '154.88', 'spread': '237.82', 'groupId': 'OG000'}, {'value': '112.92', 'spread': '135.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=110,93)', 'categories': [{'measurements': [{'value': '163.61', 'spread': '274.13', 'groupId': 'OG000'}, {'value': '128.50', 'spread': '173.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=110,93)', 'categories': [{'measurements': [{'value': '152.76', 'spread': '246.50', 'groupId': 'OG000'}, {'value': '123.83', 'spread': '173.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.44', 'spread': '8.29', 'groupId': 'OG000'}, {'value': '-2.98', 'spread': '5.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1182', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'percentage of total asleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=110,92)', 'categories': [{'measurements': [{'value': '-1.78', 'spread': '7.00', 'groupId': 'OG000'}, {'value': '-2.77', 'spread': '5.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=110,93)', 'categories': [{'measurements': [{'value': '-2.52', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '-3.16', 'spread': '5.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=110,93)', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '9.26', 'groupId': 'OG000'}, {'value': '-2.94', 'spread': '6.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110,93)', 'categories': [{'measurements': [{'value': '-2.76', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '-3.04', 'spread': '5.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=110,93)', 'categories': [{'measurements': [{'value': '-2.31', 'spread': '9.22', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '5.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=110,93)', 'categories': [{'measurements': [{'value': '-2.55', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '6.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.', 'unitOfMeasure': 'percentage of total asleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=111,94)', 'categories': [{'measurements': [{'value': '9.05', 'spread': '13.89', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '8.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=110,92)', 'categories': [{'measurements': [{'value': '7.35', 'spread': '11.94', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '5.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=110,93)', 'categories': [{'measurements': [{'value': '6.61', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '3.91', 'spread': '4.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=110,93)', 'categories': [{'measurements': [{'value': '6.41', 'spread': '11.04', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '5.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110,93)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '11.77', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '5.00', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=110,93)', 'categories': [{'measurements': [{'value': '6.68', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=110,93)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '11.17', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '6.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=110,93)', 'categories': [{'measurements': [{'value': '6.57', 'spread': '11.00', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '6.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), \\& average for double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'percentage of total asleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '14.40', 'spread': '38.14', 'groupId': 'OG000'}, {'value': '17.96', 'spread': '34.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3010', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=60,58)', 'categories': [{'measurements': [{'value': '3.72', 'spread': '54.09', 'groupId': 'OG000'}, {'value': '14.97', 'spread': '36.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=61,61)', 'categories': [{'measurements': [{'value': '17.21', 'spread': '39.97', 'groupId': 'OG000'}, {'value': '16.89', 'spread': '41.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=62,61)', 'categories': [{'measurements': [{'value': '15.72', 'spread': '57.85', 'groupId': 'OG000'}, {'value': '22.12', 'spread': '41.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=62,61)', 'categories': [{'measurements': [{'value': '18.93', 'spread': '44.73', 'groupId': 'OG000'}, {'value': '18.08', 'spread': '52.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=62,61)', 'categories': [{'measurements': [{'value': '15.36', 'spread': '51.72', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '56.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=62,61)', 'categories': [{'measurements': [{'value': '13.82', 'spread': '43.48', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '47.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=64,61)', 'categories': [{'measurements': [{'value': '351.06', 'spread': '86.05', 'groupId': 'OG000'}, {'value': '367.95', 'spread': '60.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=64,64)', 'categories': [{'measurements': [{'value': '354.11', 'spread': '94.76', 'groupId': 'OG000'}, {'value': '381.52', 'spread': '73.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=67,67)', 'categories': [{'measurements': [{'value': '366.69', 'spread': '78.34', 'groupId': 'OG000'}, {'value': '382.39', 'spread': '69.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=68,67)', 'categories': [{'measurements': [{'value': '368.58', 'spread': '86.48', 'groupId': 'OG000'}, {'value': '386.96', 'spread': '63.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=68,67)', 'categories': [{'measurements': [{'value': '368.70', 'spread': '83.39', 'groupId': 'OG000'}, {'value': '382.04', 'spread': '69.98', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=68,67)', 'categories': [{'measurements': [{'value': '365.13', 'spread': '79.31', 'groupId': 'OG000'}, {'value': '383.30', 'spread': '63.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=68,67)', 'categories': [{'measurements': [{'value': '366.47', 'spread': '81.33', 'groupId': 'OG000'}, {'value': '364.87', 'spread': '74.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=68,67)', 'categories': [{'measurements': [{'value': '365.73', 'spread': '74.47', 'groupId': 'OG000'}, {'value': '369.23', 'spread': '64.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,1,4,7,12,13,15', 'description': 'Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) \\& average for double-blind(average of weeks1,4,7,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '40.75', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '26.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7800', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=60,58)', 'categories': [{'measurements': [{'value': '9.06', 'spread': '74.76', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '18.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=61,61)', 'categories': [{'measurements': [{'value': '-2.16', 'spread': '44.61', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '27.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=62,61)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '52.95', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '26.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=62,61)', 'categories': [{'measurements': [{'value': '-3.92', 'spread': '36.22', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '57.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=62,61)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '59.32', 'groupId': 'OG000'}, {'value': '16.13', 'spread': '66.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=62,61)', 'categories': [{'measurements': [{'value': '-3.66', 'spread': '39.21', 'groupId': 'OG000'}, {'value': '6.44', 'spread': '36.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=64,61)', 'categories': [{'measurements': [{'value': '31.34', 'spread': '65.06', 'groupId': 'OG000'}, {'value': '23.89', 'spread': '24.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=64,64)', 'categories': [{'measurements': [{'value': '37.74', 'spread': '78.14', 'groupId': 'OG000'}, {'value': '26.72', 'spread': '36.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=67,67)', 'categories': [{'measurements': [{'value': '28.55', 'spread': '35.46', 'groupId': 'OG000'}, {'value': '26.62', 'spread': '43.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=68,67)', 'categories': [{'measurements': [{'value': '31.06', 'spread': '42.82', 'groupId': 'OG000'}, {'value': '26.89', 'spread': '33.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=68,67)', 'categories': [{'measurements': [{'value': '27.89', 'spread': '38.78', 'groupId': 'OG000'}, {'value': '36.93', 'spread': '57.69', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=68,67)', 'categories': [{'measurements': [{'value': '31.20', 'spread': '36.89', 'groupId': 'OG000'}, {'value': '29.22', 'spread': '35.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=68,67)', 'categories': [{'measurements': [{'value': '30.40', 'spread': '41.05', 'groupId': 'OG000'}, {'value': '43.06', 'spread': '64.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=68,67)', 'categories': [{'measurements': [{'value': '28.80', 'spread': '37.75', 'groupId': 'OG000'}, {'value': '34.35', 'spread': '40.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,1,4,7,12,13,15', 'description': 'Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) \\& average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '4.50', 'spread': '19.54', 'groupId': 'OG000'}, {'value': '-4.24', 'spread': '22.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0803', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=59,58)', 'categories': [{'measurements': [{'value': '3.17', 'spread': '16.23', 'groupId': 'OG000'}, {'value': '-6.59', 'spread': '23.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=61,61)', 'categories': [{'measurements': [{'value': '4.67', 'spread': '23.36', 'groupId': 'OG000'}, {'value': '-3.88', 'spread': '26.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=62,61)', 'categories': [{'measurements': [{'value': '6.57', 'spread': '30.27', 'groupId': 'OG000'}, {'value': '-4.19', 'spread': '25.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=62,61)', 'categories': [{'measurements': [{'value': '3.24', 'spread': '17.90', 'groupId': 'OG000'}, {'value': '-2.54', 'spread': '24.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=62,61)', 'categories': [{'measurements': [{'value': '4.98', 'spread': '22.35', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '23.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=62,61)', 'categories': [{'measurements': [{'value': '7.74', 'spread': '25.70', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '24.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=64,61)', 'categories': [{'measurements': [{'value': '60.27', 'spread': '29.51', 'groupId': 'OG000'}, {'value': '63.75', 'spread': '29.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=63,64)', 'categories': [{'measurements': [{'value': '63.53', 'spread': '31.09', 'groupId': 'OG000'}, {'value': '55.39', 'spread': '22.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=67,67)', 'categories': [{'measurements': [{'value': '64.16', 'spread': '32.11', 'groupId': 'OG000'}, {'value': '58.86', 'spread': '24.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=68,67)', 'categories': [{'measurements': [{'value': '65.81', 'spread': '35.11', 'groupId': 'OG000'}, {'value': '58.09', 'spread': '22.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=68,67)', 'categories': [{'measurements': [{'value': '62.41', 'spread': '30.09', 'groupId': 'OG000'}, {'value': '60.22', 'spread': '23.10', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=68,67)', 'categories': [{'measurements': [{'value': '63.69', 'spread': '29.90', 'groupId': 'OG000'}, {'value': '58.21', 'spread': '20.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=68,67)', 'categories': [{'measurements': [{'value': '64.09', 'spread': '31.39', 'groupId': 'OG000'}, {'value': '63.01', 'spread': '27.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=68,67)', 'categories': [{'measurements': [{'value': '67.07', 'spread': '37.40', 'groupId': 'OG000'}, {'value': '62.27', 'spread': '25.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 0,1,4,7,12,13,15', 'description': 'Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) \\& average for double-blind phase(average of weeks 1,4,7,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '4.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2643', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=59,58)', 'categories': [{'measurements': [{'value': '0.76', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=61,61)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=62,61)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=62,61)', 'categories': [{'measurements': [{'value': '0.95', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '4.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=62,61)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '4.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=62,61)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '5.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=64,61)', 'categories': [{'measurements': [{'value': '21.49', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '22.84', 'spread': '6.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=63,64)', 'categories': [{'measurements': [{'value': '22.42', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '21.86', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=67,67)', 'categories': [{'measurements': [{'value': '22.28', 'spread': '7.30', 'groupId': 'OG000'}, {'value': '22.51', 'spread': '6.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=68,67)', 'categories': [{'measurements': [{'value': '22.52', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '22.19', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=68,67)', 'categories': [{'measurements': [{'value': '22.36', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '22.37', 'spread': '6.25', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=68,67)', 'categories': [{'measurements': [{'value': '22.40', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '22.27', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=68,67)', 'categories': [{'measurements': [{'value': '22.55', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '22.48', 'spread': '7.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=68,67)', 'categories': [{'measurements': [{'value': '22.87', 'spread': '7.71', 'groupId': 'OG000'}, {'value': '22.38', 'spread': '5.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,1,4,7,12,13,15', 'description': 'Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '12.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0765', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'number of naps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=57,55)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '12.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,58)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '13.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=58,58)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '-2.83', 'spread': '16.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=58,58)', 'categories': [{'measurements': [{'value': '1.86', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '-3.47', 'spread': '15.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=58,58)', 'categories': [{'measurements': [{'value': '2.73', 'spread': '10.54', 'groupId': 'OG000'}, {'value': '-4.58', 'spread': '13.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=58,58)', 'categories': [{'measurements': [{'value': '3.41', 'spread': '11.22', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '12.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'number of naps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=62,58)', 'categories': [{'measurements': [{'value': '20.52', 'spread': '15.63', 'groupId': 'OG000'}, {'value': '22.33', 'spread': '15.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=57,55)', 'categories': [{'measurements': [{'value': '20.94', 'spread': '14.99', 'groupId': 'OG000'}, {'value': '21.69', 'spread': '15.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,58)', 'categories': [{'measurements': [{'value': '20.63', 'spread': '15.38', 'groupId': 'OG000'}, {'value': '18.90', 'spread': '13.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=58,58)', 'categories': [{'measurements': [{'value': '21.07', 'spread': '14.93', 'groupId': 'OG000'}, {'value': '19.50', 'spread': '15.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=58,58)', 'categories': [{'measurements': [{'value': '21.25', 'spread': '14.29', 'groupId': 'OG000'}, {'value': '18.86', 'spread': '15.18', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=58,58)', 'categories': [{'measurements': [{'value': '21.01', 'spread': '13.90', 'groupId': 'OG000'}, {'value': '19.66', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=58,58)', 'categories': [{'measurements': [{'value': '22.12', 'spread': '15.97', 'groupId': 'OG000'}, {'value': '17.75', 'spread': '12.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=58,58)', 'categories': [{'measurements': [{'value': '22.80', 'spread': '15.03', 'groupId': 'OG000'}, {'value': '21.69', 'spread': '14.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0,1,4,7,12,13,15', 'description': 'The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).', 'unitOfMeasure': 'number of naps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '21.26', 'spread': '196.66', 'groupId': 'OG000'}, {'value': '-40.91', 'spread': '307.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2967', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=57,55)', 'categories': [{'measurements': [{'value': '2.37', 'spread': '184.85', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '285.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,58)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '252.54', 'groupId': 'OG000'}, {'value': '-56.87', 'spread': '336.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=58,58)', 'categories': [{'measurements': [{'value': '23.03', 'spread': '220.20', 'groupId': 'OG000'}, {'value': '-31.85', 'spread': '428.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=58,58)', 'categories': [{'measurements': [{'value': '38.86', 'spread': '229.45', 'groupId': 'OG000'}, {'value': '-73.67', 'spread': '338.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=58,58)', 'categories': [{'measurements': [{'value': '64.84', 'spread': '275.99', 'groupId': 'OG000'}, {'value': '-87.50', 'spread': '291.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=58,58)', 'categories': [{'measurements': [{'value': '61.28', 'spread': '235.24', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '240.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=62,58)', 'categories': [{'measurements': [{'value': '418.49', 'spread': '368.31', 'groupId': 'OG000'}, {'value': '438.02', 'spread': '325.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=57,55)', 'categories': [{'measurements': [{'value': '399.19', 'spread': '298.18', 'groupId': 'OG000'}, {'value': '445.84', 'spread': '358.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,58)', 'categories': [{'measurements': [{'value': '403.18', 'spread': '328.59', 'groupId': 'OG000'}, {'value': '381.15', 'spread': '335.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=58,58)', 'categories': [{'measurements': [{'value': '414.68', 'spread': '315.20', 'groupId': 'OG000'}, {'value': '406.16', 'spread': '387.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=58,58)', 'categories': [{'measurements': [{'value': '430.50', 'spread': '313.11', 'groupId': 'OG000'}, {'value': '364.34', 'spread': '313.03', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=58,58)', 'categories': [{'measurements': [{'value': '412.91', 'spread': '292.66', 'groupId': 'OG000'}, {'value': '397.11', 'spread': '305.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=58,58)', 'categories': [{'measurements': [{'value': '456.48', 'spread': '352.10', 'groupId': 'OG000'}, {'value': '350.52', 'spread': '262.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=58,58)', 'categories': [{'measurements': [{'value': '452.93', 'spread': '310.68', 'groupId': 'OG000'}, {'value': '436.03', 'spread': '297.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0,1,4,7,12,13,15', 'description': 'The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '8.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0634', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.', 'unitOfMeasure': 'percentage of total asleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 1 (n=57,55)', 'categories': [{'measurements': [{'value': '1.38', 'spread': '13.89', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '7.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,58)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '9.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=58,58)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '11.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=58,58)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '9.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=58,58)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '7.96', 'groupId': 'OG000'}, {'value': '-2.63', 'spread': '8.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=58,58)', 'categories': [{'measurements': [{'value': '0.95', 'spread': '8.11', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '7.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'percentage of total asleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=62,58)', 'categories': [{'measurements': [{'value': '15.12', 'spread': '15.32', 'groupId': 'OG000'}, {'value': '14.05', 'spread': '9.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=57,55)', 'categories': [{'measurements': [{'value': '16.29', 'spread': '17.55', 'groupId': 'OG000'}, {'value': '13.89', 'spread': '10.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,58)', 'categories': [{'measurements': [{'value': '14.35', 'spread': '13.63', 'groupId': 'OG000'}, {'value': '11.92', 'spread': '9.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=58,58)', 'categories': [{'measurements': [{'value': '14.90', 'spread': '12.97', 'groupId': 'OG000'}, {'value': '12.30', 'spread': '10.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=58,58)', 'categories': [{'measurements': [{'value': '15.18', 'spread': '13.23', 'groupId': 'OG000'}, {'value': '11.36', 'spread': '9.14', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 1,4,7,12 (double blind average)(n=58,58)', 'categories': [{'measurements': [{'value': '15.16', 'spread': '12.87', 'groupId': 'OG000'}, {'value': '12.30', 'spread': '8.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=58,58)', 'categories': [{'measurements': [{'value': '15.66', 'spread': '13.84', 'groupId': 'OG000'}, {'value': '11.43', 'spread': '8.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n=58,58)', 'categories': [{'measurements': [{'value': '15.66', 'spread': '12.42', 'groupId': 'OG000'}, {'value': '14.01', 'spread': '8.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0,1,4,7,12,13,15', 'description': 'The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) \\& average for double-blind phase(average of weeks 1,4,7,12 values).', 'unitOfMeasure': 'percentage of total asleep time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.42', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '-5.67', 'spread': '5.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Multiple comparisons not applied due to only two treatments in the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and site type as fixed effects and the baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 3 (n=179,181)', 'categories': [{'measurements': [{'value': '-2.74', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '-4.94', 'spread': '5.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=180,181)', 'categories': [{'measurements': [{'value': '-3.35', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '-5.67', 'spread': '5.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=180,182)', 'categories': [{'measurements': [{'value': '-3.55', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '-5.89', 'spread': '5.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=180,182)', 'categories': [{'measurements': [{'value': '-4.05', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '-6.18', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=181,182)', 'categories': [{'measurements': [{'value': '-3.93', 'spread': '5.25', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '5.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=181,182)', 'categories': [{'measurements': [{'value': '-2.96', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '-2.96', 'spread': '5.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Insomnia Severity Index Total Scores at Various Study Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,190)', 'categories': [{'measurements': [{'value': '16.34', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '16.12', 'spread': '4.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=180,183)', 'categories': [{'measurements': [{'value': '13.52', 'spread': '5.11', 'groupId': 'OG000'}, {'value': '11.09', 'spread': '5.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=181,184)', 'categories': [{'measurements': [{'value': '12.87', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '10.40', 'spread': '5.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=181,185)', 'categories': [{'measurements': [{'value': '12.66', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '10.12', 'spread': '5.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=181,185)', 'categories': [{'measurements': [{'value': '12.16', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '9.84', 'spread': '5.63', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 3,6,9,12 (double blind average)(n=181,185)', 'categories': [{'measurements': [{'value': '12.80', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '10.36', 'spread': '5.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=182,185)', 'categories': [{'measurements': [{'value': '12.30', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '11.94', 'spread': '5.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=182,185)', 'categories': [{'measurements': [{'value': '13.28', 'spread': '5.39', 'groupId': 'OG000'}, {'value': '13.05', 'spread': '5.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 6 (n=164,165)', 'categories': [{'measurements': [{'value': '1.01', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '7.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=165,166)', 'categories': [{'measurements': [{'value': '1.38', 'spread': '7.60', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '7.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=166,166)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '7.99', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '6.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 6, 12, 16', 'description': "Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Physical Component Summary of the Short Form-36 Scale Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,190)', 'categories': [{'measurements': [{'value': '43.99', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '45.39', 'spread': '9.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=165,168)', 'categories': [{'measurements': [{'value': '45.06', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '46.08', 'spread': '10.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=166,169)', 'categories': [{'measurements': [{'value': '45.38', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '46.12', 'spread': '9.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=167,169)', 'categories': [{'measurements': [{'value': '44.70', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '45.51', 'spread': '9.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,6,12,16', 'description': "This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 6 (n=164,165)', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '7.45', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '8.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=165,166)', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '8.00', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '8.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=166,166)', 'categories': [{'measurements': [{'value': '-1.22', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '7.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 6,12,16', 'description': "Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Mental Component Summary of the Short Form-36 Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,190)', 'categories': [{'measurements': [{'value': '49.69', 'spread': '9.33', 'groupId': 'OG000'}, {'value': '49.29', 'spread': '10.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=165,168)', 'categories': [{'measurements': [{'value': '49.49', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '49.96', 'spread': '10.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=166,169)', 'categories': [{'measurements': [{'value': '48.98', 'spread': '10.19', 'groupId': 'OG000'}, {'value': '49.86', 'spread': '9.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=167,169)', 'categories': [{'measurements': [{'value': '48.68', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '49.23', 'spread': '9.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,6,12,16', 'description': "This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)\\& non-drug treatment follow-up(week 16).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Sheehan Disability Scale Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 6 (n=164,165)', 'categories': [{'measurements': [{'value': '-2.60', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '-4.05', 'spread': '7.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=165,166)', 'categories': [{'measurements': [{'value': '-3.73', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '-4.48', 'spread': '7.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=166,166)', 'categories': [{'measurements': [{'value': '-3.11', 'spread': '7.88', 'groupId': 'OG000'}, {'value': '-3.52', 'spread': '7.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=166,166)', 'categories': [{'measurements': [{'value': '-3.33', 'spread': '8.09', 'groupId': 'OG000'}, {'value': '-2.47', 'spread': '7.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Weeks 6,12,14,16', 'description': "Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability \\& includes: work/school, social life, family life/home responsibilities, days lost \\&days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}, {'type': 'SECONDARY', 'title': 'Mean Sheehan Disability Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'OG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'classes': [{'title': 'Week 0 (n=192,190)', 'categories': [{'measurements': [{'value': '11.38', 'spread': '7.80', 'groupId': 'OG000'}, {'value': '11.13', 'spread': '7.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=165,168)', 'categories': [{'measurements': [{'value': '8.87', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '6.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=166,169)', 'categories': [{'measurements': [{'value': '7.70', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '7.08', 'spread': '6.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n=166,166)', 'categories': [{'measurements': [{'value': '8.37', 'spread': '7.21', 'groupId': 'OG000'}, {'value': '8.03', 'spread': '7.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=167,169)', 'categories': [{'measurements': [{'value': '8.12', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '9.06', 'spread': '7.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0,6,12,14,16', 'description': "Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)\\& follow-up(weeks 14,16).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'FG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}], 'periods': [{'title': 'Double Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Didnt Meet Entry/Randomization Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Follow up:2 Week Placebo, 2 Week no Drug', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two subjects withdrew consent prior to starting the follow up period.', 'groupId': 'FG000', 'numSubjects': '146'}, {'comment': 'Two subjects withdrew consent prior to starting the follow up period.', 'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'BG001', 'title': 'Eszopiclone', 'description': 'Eszopiclone 2 mg tablets'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '71.6', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '72.0', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.28', 'spread': '4.98', 'groupId': 'BG000'}, {'value': '28.25', 'spread': '4.90', 'groupId': 'BG001'}, {'value': '27.76', 'spread': '4.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women', 'unitOfMeasure': 'Kilograms/Meters squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '165.90', 'spread': '9.83', 'groupId': 'BG000'}, {'value': '164.70', 'spread': '10.04', 'groupId': 'BG001'}, {'value': '165.30', 'spread': '9.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.44', 'spread': '17.07', 'groupId': 'BG000'}, {'value': '76.98', 'spread': '16.72', 'groupId': 'BG001'}, {'value': '76.21', 'spread': '16.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant Weight in Kilograms', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-12', 'studyFirstSubmitDate': '2006-10-09', 'resultsFirstSubmitDate': '2009-02-13', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-06', 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose)-12 weeks', 'description': 'The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.', 'timeFrame': 'Weeks 0, 3, 6, 9, 12, 14, 16', 'description': 'The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.'}, {'measure': 'Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.', 'timeFrame': 'Weeks 0, 3, 6, 9, 12, 14, 16', 'description': 'The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - Week12', 'description': 'Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Sleep Latency Reported at Various Study Time Points.', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) -week 12', 'description': 'Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), weeks 3,6,9,12,14,16', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - Week12', 'description': 'The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Number of Awakenings (Subject-reported) at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - Week12', 'description': 'Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points', 'timeFrame': 'weeks 0,3,6,9,12,14,16', 'description': 'Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Depth of Sleep at Various Study Time Points', 'timeFrame': 'weeks 0,3,6,9,12,14,16', 'description': 'Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Daytime Alertness at Various Study Time Points.', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Ability to Function at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) \\& average for double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.', 'timeFrame': 'Baseliine (week 0), Day 1 (post first dose) - week 12', 'description': 'Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Ability to Concentrate at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) \\& average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-reported Physical Well-Being at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), \\& average for double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose)- week 12', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-Reported Total Nap Time at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.'}, {'measure': 'Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), \\& average for double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points', 'timeFrame': 'Weeks 0,1,4,7,12,13,15', 'description': 'Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) \\& average for double-blind(average of weeks1,4,7,12 values).'}, {'measure': 'Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.', 'timeFrame': 'Weeks 0,1,4,7,12,13,15', 'description': 'Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.'}, {'measure': 'Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'weeks 0,1,4,7,12,13,15', 'description': 'Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) \\& average for double-blind phase(average of weeks 1,4,7,12 values).'}, {'measure': 'Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'Weeks 0,1,4,7,12,13,15', 'description': 'Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).'}, {'measure': 'Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'Week 0,1,4,7,12,13,15', 'description': 'The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).'}, {'measure': 'Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.', 'timeFrame': 'Week 0,1,4,7,12,13,15', 'description': 'The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).'}, {'measure': 'Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 1,4,7,12,13,15', 'description': 'Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points', 'timeFrame': 'Week 0,1,4,7,12,13,15', 'description': 'The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) \\& average for double-blind phase(average of weeks 1,4,7,12 values).'}, {'measure': 'Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period', 'timeFrame': 'Baseline (week 0), Day 1 (post first dose) - week 12', 'description': 'Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.'}, {'measure': 'Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points', 'timeFrame': 'Baseline (week 0), Weeks 3,6,9,12,14,16', 'description': 'Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.'}, {'measure': 'Mean Insomnia Severity Index Total Scores at Various Study Time Points', 'timeFrame': 'Weeks 0,3,6,9,12,14,16', 'description': 'The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).'}, {'measure': 'Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale', 'timeFrame': 'Baseline (week 0), Weeks 6, 12, 16', 'description': "Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value."}, {'measure': 'Mean Physical Component Summary of the Short Form-36 Scale Scores.', 'timeFrame': 'Weeks 0,6,12,16', 'description': "This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16)."}, {'measure': 'Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores', 'timeFrame': 'Baseline (week 0), Weeks 6,12,16', 'description': "Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value."}, {'measure': 'Mean Mental Component Summary of the Short Form-36 Scale Scores', 'timeFrame': 'Weeks 0,6,12,16', 'description': "This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)\\& non-drug treatment follow-up(week 16)."}, {'measure': 'Mean Change From Baseline in the Sheehan Disability Scale Total Score.', 'timeFrame': 'Baseline (week 0), Weeks 6,12,14,16', 'description': "Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability \\& includes: work/school, social life, family life/home responsibilities, days lost \\&days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value."}, {'measure': 'Mean Sheehan Disability Total Scores', 'timeFrame': 'Weeks 0,6,12,14,16', 'description': "Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)\\& follow-up(weeks 14,16)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insomnia', 'chronic', 'primary'], 'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '20175406', 'type': 'RESULT', 'citation': 'Ancoli-Israel S, Krystal AD, McCall WV, Schaefer K, Wilson A, Claus R, Rubens R, Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep. 2010 Feb;33(2):225-34. doi: 10.1093/sleep/33.2.225.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.', 'detailedDescription': "A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.\n\nExclusion Criteria:\n\n* Subject has recent history of known clinically significant abnormal laboratory findings.'}, 'identificationModule': {'nctId': 'NCT00386334', 'briefTitle': 'A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia', 'orgStudyIdInfo': {'id': '190-904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Week -2 to day 0 single blind one tablet placebo in the evening. Double blind period: Day 1 to Week 12 double blind one tablet placebo in the evening. Follow up period: two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Eszopiclone', 'description': 'Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.', 'interventionNames': ['Drug: Eszopiclone', 'Drug: Placebo']}], 'interventions': [{'name': 'Eszopiclone', 'type': 'DRUG', 'otherNames': ['Lunesta'], 'description': '2 mg tablet once per day in the evening', 'armGroupLabels': ['Eszopiclone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet one per day in the evening.', 'armGroupLabels': ['Eszopiclone', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35226', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85712', 'city': 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'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}