Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-08 @ 1:07 AM
Study NCT ID:
NCT02865460
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coenzyme Q10 Phase III Trial in Gulf War Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003741', 'term': 'ubiquinol'}, {'id': 'C024989', 'term': 'coenzyme Q10'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nancy.klimas@va.gov', 'phone': '305-575-7000', 'title': 'Nancy Klimas, MD', 'phoneExt': '1-4800', 'organization': 'Miami VA Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study recruitment closed on 4/1/2020, coinciding with the onset of the COVID-19 pandemic. Participants could not complete their in-person visits due to the closure of VA research services and VA outpatient labs.'}}, 'adverseEventsModule': {'timeFrame': '28 weeks', 'description': 'All participants assigned to a study arm or comparison group comprised the at risk population.', 'eventGroups': [{'id': 'EG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Veterans Short Form 36-Item Health Survey Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change Baseline to 4 Weeks', 'categories': [{'measurements': [{'value': '1.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 8 Weeks', 'categories': [{'measurements': [{'value': '1.4', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 12 Weeks', 'categories': [{'measurements': [{'value': '1.5', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 16 Weeks', 'categories': [{'measurements': [{'value': '2.1', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 20 Weeks', 'categories': [{'measurements': [{'value': '1.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 24 Weeks', 'categories': [{'measurements': [{'value': '0.7', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': "Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Multidimensional Fatigue Inventory (MFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change Baseline to 4 Weeks', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 8 Weeks', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 12 Weeks', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '10', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 16 Weeks', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 20 Weeks', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 24 Weeks', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The Multidimensional Fatigue Inventory score is 0-100. The higher value indicates more fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Gulf War Illness Health Symptom Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 4 weeks', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 20 weeks', 'categories': [{'measurements': [{'value': '-6.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 28 weeks', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28', 'description': 'The Gulf War Illness Health Symptoms Checklist asks questions about symptoms related to Gulf War Illness. The linear scale is 0-42. The higher value indicates more symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 4 weeks', 'categories': [{'measurements': [{'value': '0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 20 weeks', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 4 weeks', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 20 weeks', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'The PSQI measures quality and patterns of sleep and wake cycles and is completed by the participant. The Pittsburgh Sleep Quality Index scale is 0-21. The higher value indicates more sleep disturbance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Hamilton Anxiety Scale (HAM-A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Hamilton Depression Scale (HAM-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'This measure allows the participant to rate level of depression. The Hamilton Depression Scale is a linear scale 0-62. The higher value indicates more depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 4 weeks', 'categories': [{'measurements': [{'value': '4.5', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '4.2', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '4.0', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '3.8', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 20 weeks', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '2.6', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': "Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The Veterans Short Form 36-item Health Survey Mental Component Score scale is 0-100. The higher value indicates more favorable mental health.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Connors Continuous Performance Test (CPT-3): Hit Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '10.7', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '34.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '17.2', 'spread': '46.9', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '49', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '24.0', 'spread': '46.9', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '45.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Hit Reaction Time scale is 0-No limit. The higher score indicates poorer outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Connors Continuous Performance Test (CPT-3):Omissions T-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Omissions score is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher T-score indicates poorer outcomes.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Connors Continuous Performance Test (CPT-3):Commissions T-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Commissions T-score scale is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher score indicates poorer outcomes.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Brief Visual Memory Test (BVMT): Delayed Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to8 weeks', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Delayed Recall scale is 0-12. The higher value indicates better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Brief Visual Memory Test (BVMT): Percent Retained', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '42.9', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '43', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-5.6', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '24.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '52.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '39.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Percent Retained score is 0-100. The higher value indicates better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'California Verbal Learning Test (CVLT-II): Correct Trials # 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '0.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '4.0', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '5.8', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '10.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Correct Trials #1-5 score is 0-80. The higher score indicates better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'California Verbal Learning Test (CVLT-II): Short Delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Short Delay Test scale is 0-16. The higher score indicates better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'California Verbal Learning Test (CVLT-II): Long Delay Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Long Delay Test scale is 0-16. The higher score indicates better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Davidson Trauma Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-13.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '21.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'FitBit Sleep Measurement - Total Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Average Total Sleep, Baseline to Week 8', 'categories': [{'measurements': [{'value': '344.14', 'spread': '54.6', 'groupId': 'OG000'}, {'value': '343.4', 'spread': '59.8', 'groupId': 'OG001'}]}]}, {'title': 'Average Total Sleep, Week 8 to Week 16', 'categories': [{'measurements': [{'value': '346.31', 'spread': '60.85', 'groupId': 'OG000'}, {'value': '348.15', 'spread': '57.57', 'groupId': 'OG001'}]}]}, {'title': 'Average Total Sleep, Week 16 to Week 24', 'categories': [{'measurements': [{'value': '350.98', 'spread': '58.28', 'groupId': 'OG000'}, {'value': '334.22', 'spread': '70.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks', 'description': "FitBit measures the duration of sleep daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'FitBit Sleep Measurement - Types of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Asleep, Baseline to Week 8', 'categories': [{'measurements': [{'value': '89.06', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '88.57', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Asleep, Week 8 to Week 16', 'categories': [{'measurements': [{'value': '89.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '88.5', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Asleep, Week 16 to Week 24', 'categories': [{'measurements': [{'value': '88.81', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '88.85', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Awake, Baseline to Week 8', 'categories': [{'measurements': [{'value': '10.68', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '11.34', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Awake, Week 8 to Week 16', 'categories': [{'measurements': [{'value': '10.64', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '11.43', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Awake, Week 16 to Week 24', 'categories': [{'measurements': [{'value': '10.92', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '11.09', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Light Sleep, Baseline to Week 8', 'categories': [{'measurements': [{'value': '65.37', 'spread': '6.23', 'groupId': 'OG000'}, {'value': '64.68', 'spread': '7.21', 'groupId': 'OG001'}]}]}, {'title': 'Light Sleep, Week 8 to Week 16', 'categories': [{'measurements': [{'value': '67.31', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '65.89', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Light Sleep, Week 16 to Week 24', 'categories': [{'measurements': [{'value': '64.49', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '65.28', 'spread': '7.98', 'groupId': 'OG001'}]}]}, {'title': 'Deep Sleep, Baseline to Week 8', 'categories': [{'measurements': [{'value': '15.29', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '5.97', 'groupId': 'OG001'}]}]}, {'title': 'Deep Sleep, Week 8 to Week 16', 'categories': [{'measurements': [{'value': '14.04', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '13.82', 'spread': '5.48', 'groupId': 'OG001'}]}]}, {'title': 'Deep Sleep, Week 16 to Week 24', 'categories': [{'measurements': [{'value': '15.78', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '15.23', 'spread': '5.86', 'groupId': 'OG001'}]}]}, {'title': 'REM Sleep, Baseline to Week 8', 'categories': [{'measurements': [{'value': '19.33', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'REM Sleep, Week 8 to Week 16', 'categories': [{'measurements': [{'value': '18.65', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '20.21', 'spread': '3.43', 'groupId': 'OG001'}]}]}, {'title': 'REM Sleep, Week 16 to Week 24', 'categories': [{'measurements': [{'value': '19.74', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '18.75', 'spread': '4.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks', 'description': "FitBit measures the time spent in each type of sleep (Light, Deep, Rapid Eye Movement (REM)) daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available.", 'unitOfMeasure': 'average percentage of total time in bed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'WBC, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '0.41', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.22', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.22', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '74.64', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '26.20', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-5.88', 'spread': '79.94', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '31.36', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-6.00', 'spread': '78.07', 'groupId': 'OG000'}, {'value': '14.48', 'spread': '48.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: white blood cell (WBC) counts and platelets. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': '1000 cells per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'RBC, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'RBC, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'RBC, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: red blood cell counts. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': '1000000 cells per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Neutrophils, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '2.08', 'spread': '15.11', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '9.25', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.26', 'spread': '13.97', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '9.36', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '3.33', 'spread': '14.81', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '10.95', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-1.64', 'spread': '12.29', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '7.83', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '12.73', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '7.66', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-3.01', 'spread': '13.22', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '8.68', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.07', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of white blood cells. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'percentage of white blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.17', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.10', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: hemoglobin. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from baseline to 8 weeks', 'categories': [{'measurements': [{'value': '0.73', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 16 weeks', 'categories': [{'measurements': [{'value': '0.63', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '3.41', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 24 weeks', 'categories': [{'measurements': [{'value': '0.53', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of hematocrit in blood. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'percentage of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.344', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Cortisol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Waking, Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Morning, Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Evening, Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Sleep, Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Waking, Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Morning, Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Evening, Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Sleep, Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Waking, Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Morning, Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Evening, Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Sleep, Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.', 'description': 'Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.', 'unitOfMeasure': 'micrograms/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'HPG will measure testosterone. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'HPG will measure progesterone. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'classes': [{'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '6.06', 'spread': '25.64', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '7.51', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 16', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '6.55', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '6.21', 'spread': '27.90', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '8.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'HPG will measure estradiol. Average values fell within the normal range for this type of assay.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Ubiquinol group -not deployed to Gulf; Placebo group- ill with COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking\n\nUbiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking\n\nPlacebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '6', 'groupId': 'BG000'}, {'value': '53', 'spread': '5', 'groupId': 'BG001'}, {'value': '54', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intention-to-treat'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'SF 36 Physical Component Summary (PCS)', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '23', 'groupId': 'BG000'}, {'value': '56', 'spread': '22', 'groupId': 'BG001'}, {'value': '56', 'spread': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The scale is 1-100. The higher value indicates better physical health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intention-to-treat'}], 'populationDescription': 'Number of all participants for whom baseline characteristics were measured, in each arm/group and in the entire study population (total).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-19', 'size': 589285, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-29T15:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2016-07-28', 'resultsFirstSubmitDate': '2022-07-29', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-10', 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Veterans Short Form 36-Item Health Survey Physical Component Summary', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': "Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health."}], 'secondaryOutcomes': [{'measure': 'Multidimensional Fatigue Inventory (MFI)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The Multidimensional Fatigue Inventory score is 0-100. The higher value indicates more fatigue.'}, {'measure': 'Gulf War Illness Health Symptom Checklist', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28', 'description': 'The Gulf War Illness Health Symptoms Checklist asks questions about symptoms related to Gulf War Illness. The linear scale is 0-42. The higher value indicates more symptoms.'}, {'measure': 'Brief Pain Inventory', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'The PSQI measures quality and patterns of sleep and wake cycles and is completed by the participant. The Pittsburgh Sleep Quality Index scale is 0-21. The higher value indicates more sleep disturbance.'}, {'measure': 'Hamilton Anxiety Scale (HAM-A)', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety.'}, {'measure': 'Hamilton Depression Scale (HAM-D)', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'This measure allows the participant to rate level of depression. The Hamilton Depression Scale is a linear scale 0-62. The higher value indicates more depression.'}, {'measure': 'Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': "Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The Veterans Short Form 36-item Health Survey Mental Component Score scale is 0-100. The higher value indicates more favorable mental health."}, {'measure': 'Connors Continuous Performance Test (CPT-3): Hit Reaction Time', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Hit Reaction Time scale is 0-No limit. The higher score indicates poorer outcomes.'}, {'measure': 'Connors Continuous Performance Test (CPT-3):Omissions T-score', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Omissions score is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher T-score indicates poorer outcomes.'}, {'measure': 'Connors Continuous Performance Test (CPT-3):Commissions T-score', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Commissions T-score scale is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher score indicates poorer outcomes.'}, {'measure': 'Brief Visual Memory Test (BVMT): Delayed Recall', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Delayed Recall scale is 0-12. The higher value indicates better performance.'}, {'measure': 'Brief Visual Memory Test (BVMT): Percent Retained', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Percent Retained score is 0-100. The higher value indicates better performance.'}, {'measure': 'California Verbal Learning Test (CVLT-II): Correct Trials # 1-5', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Correct Trials #1-5 score is 0-80. The higher score indicates better performance.'}, {'measure': 'California Verbal Learning Test (CVLT-II): Short Delay', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Short Delay Test scale is 0-16. The higher score indicates better performance.'}, {'measure': 'California Verbal Learning Test (CVLT-II): Long Delay Test', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Long Delay Test scale is 0-16. The higher score indicates better performance.'}, {'measure': 'Davidson Trauma Scale', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.'}, {'measure': 'FitBit Sleep Measurement - Total Sleep', 'timeFrame': 'Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks', 'description': "FitBit measures the duration of sleep daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available."}, {'measure': 'FitBit Sleep Measurement - Types of Sleep', 'timeFrame': 'Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks', 'description': "FitBit measures the time spent in each type of sleep (Light, Deep, Rapid Eye Movement (REM)) daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available."}, {'measure': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: white blood cell (WBC) counts and platelets. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: red blood cell counts. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of white blood cells. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: hemoglobin. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of hematocrit in blood. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy on Cortisol Levels', 'timeFrame': 'Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.', 'description': 'Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.'}, {'measure': 'Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'HPG will measure testosterone. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'HPG will measure progesterone. Average values fell within the normal range for this type of assay.'}, {'measure': 'Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'HPG will measure estradiol. Average values fell within the normal range for this type of assay.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'Cognitive Disorders', 'Inflammation', 'Neurologic manifestations', 'Dementia', 'Mental Disorders', 'Ubiquinol/ubiquinone', 'Pathologic Processes', 'Nervous System Diseases', 'Hormones, Hormone Substitutes, and Hormone Antagon', 'Anti-Inflammatory Agents', 'Pharmacologic Actions', 'Therapeutic Uses', 'Physiological Effects of Drugs', 'Gulf war illness', 'Chronic fatigue'], 'conditions': ['Gulf War Illness', 'Chronic Fatigue', 'Ubiquinol', 'Coenzyme Q10']}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.', 'detailedDescription': 'As many as a third of the nearly 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti Theater of Operations are suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by multiple symptoms. Gulf War Veterans experienced environmental exposures that are known to be oxidative stressors which contribute to cell injury, resulting in mitochondrial dysfunction Exploratory studies using interventions that support cell functioning and prevent or repair stress mediators suggest a role for these targeted interventions, such as Coenzyme Q10. The goal of this clinical trial is to determine if Coenzyme Q10 is effective in increasing physical functioning for Veterans with Gulf War Illness.\n\nThis is a randomized, two group, double blind, placebo controlled, Phase III clinical trial. The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome measure for this clinical trial is a change from baseline of SF-36, with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain, fatigue, sleep issues, and cognitive impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female Veterans who were deployed in 1990 -1991 Gulf War.\n* Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.\n* Veterans who were in good health based on medical history prior to 1990.\n* Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.\n\nExclusion Criteria:\n\n* Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:\n\n * severe psychiatric problems\n * schizophrenia\n * bipolar disorder\n * major depression with psychotic or melancholic features\n * delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry.\n * Has dementias of any type\n * Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003).\n * Is pregnant or breastfeeding or plans to become pregnant within the next 6 months.\n* Medical conditions excluded:\n\n * organ failure\n * defined rheumatologic inflammatory disorders\n * chronic active infections such as HIV, hepatitis B and C, or transplant\n * primary sleep disorders\n* Medications that could potentially impact immune function excluded:\n\n * steroids\n * immune-suppressives\n * nutraceuticals that are formulated to impact mitochondrial function or oxidative stress\n * Biologic response modifiers within 3 months of study entry.\n* Current use of Coumadin (given the vitamin K structural similarity of CoQ10)\n* Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules\n* Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits.\n* Common multivitamin preparations will be allowed if taken without change throughout the protocol.'}, 'identificationModule': {'nctId': 'NCT02865460', 'briefTitle': 'Coenzyme Q10 Phase III Trial in Gulf War Illness', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness', 'orgStudyIdInfo': {'id': 'SPLD-04-15F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ubiquinol', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking', 'interventionNames': ['Drug: Ubiquinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ubiquinol', 'type': 'DRUG', 'otherNames': ['Coenzyme Q10, CoQ10'], 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking', 'armGroupLabels': ['Ubiquinol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill, inactive substance'], 'description': 'Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami VA Healthcare System, Miami, FL', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters VA Medical Center, Bronx, NY', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Nancy G Klimas, BS MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miami VA Healthcare System, Miami, FL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}