Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT04070157
Status:
TERMINATED
Last Update Posted:
2024-10-21
First Post:
2019-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C025655', 'term': 'lofexidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@usworldmeds.com', 'phone': '1-888-900-8796', 'title': 'Medical Affairs', 'organization': 'USWM, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 of drug administration through 30 day follow up, up to 57 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Treatment Emergent AEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 28', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "There were zero Treatment Emergent AE's."}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 28', 'description': 'The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a "yes" in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds "yes" to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral.', 'unitOfMeasure': '% of subjects with suicide risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All responses were "No".'}, {'type': 'PRIMARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine: Sitting', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Lofexidine: Standing', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG002', 'title': 'Placebo: Sitting', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG003', 'title': 'Placebo: Standing', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '3.06', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '3.21', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '1.53', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '3', 'spread': '5.66', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '7', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-9', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '3.87', 'groupId': 'OG002'}, {'value': '5', 'spread': '6', 'groupId': 'OG003'}]}]}, {'title': 'Day 3: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-52', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-44', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '7.72', 'groupId': 'OG002'}, {'value': '6', 'spread': '7.94', 'groupId': 'OG003'}]}]}, {'title': 'Day 7: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '7', 'spread': '8.72', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '6', 'spread': '7', 'groupId': 'OG002'}]}]}, {'title': 'Day 8: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-8', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '9.45', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '5.86', 'groupId': 'OG003'}]}]}, {'title': 'Day 8: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-44', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-36', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '4', 'spread': '11', 'groupId': 'OG002'}, {'value': '3', 'spread': '11', 'groupId': 'OG003'}]}]}, {'title': 'Day 14: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-42', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '10.02', 'groupId': 'OG002'}]}]}, {'title': 'Day 15: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '1', 'spread': '7.81', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '7.77', 'groupId': 'OG003'}]}]}, {'title': 'Day 15: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-32', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-40', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '16.07', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '13.01', 'groupId': 'OG003'}]}]}, {'title': 'Day 18: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '6.35', 'groupId': 'OG002'}]}]}, {'title': 'Day 18: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '0.58', 'groupId': 'OG002'}]}]}, {'title': 'Day 19: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 19: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '6.22', 'groupId': 'OG002'}]}]}, {'title': 'Day 20: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '5.91', 'groupId': 'OG002'}]}]}, {'title': 'Day 20: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '7.68', 'groupId': 'OG002'}]}]}, {'title': 'Day 21: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '3.42', 'groupId': 'OG002'}]}]}, {'title': 'Day 21: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '11.12', 'groupId': 'OG002'}]}]}, {'title': 'Day 22: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-8', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.72', 'groupId': 'OG002'}, {'value': '10', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'Day 22: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-34', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '16.02', 'groupId': 'OG002'}, {'value': '16', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'Day 23: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '5.45', 'groupId': 'OG002'}]}]}, {'title': 'Day 23: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '12.23', 'groupId': 'OG002'}]}]}, {'title': 'Day 24: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 24: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-23.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '6.61', 'groupId': 'OG002'}]}]}, {'title': 'Day 25: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '3.56', 'groupId': 'OG002'}]}]}, {'title': 'Day 25: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '9.57', 'groupId': 'OG002'}]}]}, {'title': 'Day 26: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '7.46', 'groupId': 'OG002'}]}]}, {'title': 'Day 26: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '19.28', 'groupId': 'OG002'}]}]}, {'title': 'Day 27: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '4.67', 'groupId': 'OG002'}]}]}, {'title': 'Day 27: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '8.16', 'groupId': 'OG002'}]}]}, {'title': 'Day 28: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '4.95', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '14.85', 'groupId': 'OG003'}]}]}, {'title': 'Day 29: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}]}]}, {'title': 'Day 29: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}]}]}, {'title': 'Day 30: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}]}]}, {'title': 'Day 30: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}]}]}, {'title': 'Day 34: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}]}]}, {'title': 'Day 34: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}]}]}, {'title': 'Day 37: Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}, {'value': '3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG003'}]}]}, {'title': 'Day 37: Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG002'}, {'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'description': 'Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. Orthostatic vital signs only collected in clinic.'}, {'type': 'PRIMARY', 'title': 'Change in Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine: Sitting', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Lofexidine: Standing', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG002', 'title': 'Placebo: Sitting', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG003', 'title': 'Placebo: Standing', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '-5', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '3.21', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-9', 'spread': '4.24', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '-7.3', 'spread': '2.63', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '0.58', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2', 'spread': '9.54', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '-1', 'spread': '3.46', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.58', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '7.09', 'groupId': 'OG002'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '-11', 'spread': '8.19', 'groupId': 'OG002'}, {'value': '-3', 'spread': '3.46', 'groupId': 'OG003'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '4.03', 'groupId': 'OG002'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '5.12', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '8.54', 'groupId': 'OG002'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG001'}, {'value': '-6', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '-7', 'spread': '2.83', 'groupId': 'OG003'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': '11.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '7.78', 'groupId': 'OG002'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-9', 'spread': '4.97', 'groupId': 'OG002'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '7.31', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '3.54', 'groupId': 'OG002'}, {'value': '-7', 'spread': '11.31', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': 'NA', 'comment': 'Only 1 participant remaining in Placebo group, standard deviation not possible.', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': 'NA', 'comment': 'Only 1 participant remaining in Placebo group, standard deviation not possible.', 'groupId': 'OG002'}]}]}, {'title': 'Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': 'NA', 'comment': 'Only 1 participant remaining in Placebo group, standard deviation not possible.', 'groupId': 'OG002'}]}]}, {'title': 'Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13', 'spread': 'NA', 'comment': 'Only 1 participant remaining in Placebo group, standard deviation not possible.', 'groupId': 'OG002'}, {'value': '-8', 'spread': 'NA', 'comment': 'Only 1 participant remaining in Placebo group, standard deviation not possible.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. Orthostatic vital signs only collected in clinic.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Opiate Withdrawal Scale (COWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28', 'description': 'The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '3.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '5.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '5.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '5.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '4.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '6.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.49', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-3', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'description': 'The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. All remaining blank fields had no data collection.'}, {'type': 'SECONDARY', 'title': 'Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '5.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '3', 'spread': '6.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '8.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '7.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '6.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '8.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'description': 'The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. All remaining blank fields had no data collection.'}, {'type': 'SECONDARY', 'title': 'Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine Severity of Illness Scale Averages:', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo Severity of Illness Scale Averages:', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG002', 'title': 'Lofexidine Side Effects Index Averages:', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG003', 'title': 'Placebo Side Effects Index Averages:', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Visit 2', 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG000'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG002'}, {'value': '1.33', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG000'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG000'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'EOS', 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG000'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only 1 participant. Standard deviation not possible.', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)', 'description': "MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug.\n\nSEVERITY OF ILLNESS:\n\n1. = No at all ill\n2. = Borderline ill\n3. = Mildly ill\n4. = Moderately ill\n5. = Markedly ill\n6. = Severely ill\n7. = Among the most extremely ill subjects\n\nSIDE EFFECTS INDEX:\n\n1. = None, study drug is producing no side effects\n2. = Do not significantly interfere with subject's functioning\n3. = Significantly interferes with subject's functioning\n4. = Outweighs therapeutic effect", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Clinical Global Impression - Subject Version (MCGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine Severity of Opiate Withdrawal Averages:', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo Severity of Opiate Withdrawal Averages:', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG002', 'title': 'Lofexidine Side Effects Index Averages:', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG003', 'title': 'Placebo Side Effects Index Averages:', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '0.471', 'groupId': 'OG003'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.471', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'spread': 'NA', 'comment': 'Standard deviation not possible as values were the same for all participants.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Each scheduled evaluation (Day 1 through Day 28)', 'description': 'Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug.\n\nSEVERITY OF OPIATE WITHDRAWAL:\n\n1. = No opiate withdrawal symptoms\n2. = On the border between no to mild opiate withdrawal symptoms\n3. = Mild opiate withdrawal symptoms\n4. = Moderate opiate withdrawal symptoms\n5. = Marked opiate withdrawal symptoms\n6. = Severe opiate withdrawal symptoms\n7. = The most severe opiate withdrawal symptoms that I have ever had\n\nSIDE EFFECTS INDEX (Scale B):\n\n1. = None. The study drug has no side effects\n2. = The study drug has slight side effects, but it does NOT significantly interfere with my day to day activities\n3. = The study drug has moderate side effects, and it DOES significantly interfere with my day to day activities\n4. = The study drug has severe side effects, and these side effects are greater than the relief from opiate withdrawal symptoms that it provides', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Time to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo: Patient 1', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG002', 'title': 'Placebo: Patient 2', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG003', 'title': 'Placebo: Patient 3', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 28', 'description': 'Study day of participant discontinuation.', 'unitOfMeasure': 'Days to study discontinuation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo: Patient 1', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG002', 'title': 'Placebo: Patient 2', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG003', 'title': 'Placebo: Patient 3', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1-15:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Day 16- Day 28:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 28', 'unitOfMeasure': 'Number concomitant medication', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': 'NA', 'comment': 'No standard deviation since only 1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.462', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to EOS', 'description': 'The EQ-5D-5L is an instrument that evaluates preference for health status through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of which are rated on 5 levels of severity. Each dimension ranges from a minimum of "0 - I have no problems or I am not" to a maximum of "5 - I am unable to or I am extremely". The dimensions are averaged together for a single score and the change in average score from baseline is recorded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short Form Health Survey (SF-36) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to End of Study, up to 55 days', 'description': 'The SF-36 consists of 36 questions that measure various aspects of physical and mental well-being. Precoded values are recorded for each question ranging from 0-100, with a high score defined as a more favorable health status. The items are then averaged together to create the 8 scale scores which are averaged together to create a scale.\n\nThe final value reported is the average change in the averaged scale scores from baseline to end of study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Insomnia Severity Index (ISI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-4', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'categories': [{'measurements': [{'value': '-9', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to Days 15 and End of Study, up to 55 days', 'description': 'The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item on a scale 0 to 4 for each of the 7 items, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '3.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from End of Study to Baseline, up to 55 days', 'description': 'The HADS is a self-reported screening tool for anxiety and depression in nonpsychiatric clinical populations. Responses are based on the relative frequency of symptoms over the preceding week. The scale consists of 14 items, with a subscale of 7 questions for anxiety and 7 questions for depression. Patients rate each item in the subscales on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Possible scores range from 0 to 21 for each subscale. An analysis of scores on the 2 subscales supported the differentiation of each mood state into 4 ranges: non-cases (scores 0 to 7), mild cases (scores 8 to 10), moderate cases (scores 11 to 15), and severe cases (scores 16 or higher), with lower values being favorable. The subscales are then combined for a total score ranging from 0 to 42. Higher scores indicate greater levels of anxiety or depression. The value reported is the average change from baseline to End of Study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 41', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Follow-up (assessed daily)', 'description': 'A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain.\n\nThe format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 28 (assessed daily)', 'description': 'The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 41', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '2', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '1', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Day 51 (assessed daily)', 'description': 'The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-1', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 28 (assessed daily)', 'description': 'The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-100', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-30', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-65', 'spread': '49.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-63.3', 'spread': '35.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-66.7', 'spread': '40.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-80', 'spread': '62.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-75', 'spread': '25.98', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-60.8', 'spread': '34.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-93.3', 'spread': '50.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-45', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-78.3', 'spread': '29.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-67.5', 'spread': '31.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-78.3', 'spread': '29.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-145', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-155', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-20', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Day 28', 'unitOfMeasure': 'MME (morphine milligram equivalent)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Opioid Dose as a Percentage of the Baseline MED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-50', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-50', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-51.7', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-58.3', 'spread': '14.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-65', 'spread': '17.32', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-52.1', 'spread': '21.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-74.2', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-56.3', 'spread': '26.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-66.7', 'spread': '14.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-75', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.7', 'spread': '14.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-72.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-77.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}, {'value': '-10', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant in Lofexidine group.', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10', 'spread': 'NA', 'comment': 'No standard deviation because only 1 participant with recorded data.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Day 28', 'unitOfMeasure': 'MME (morphine milligram equivalent)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collection for field with 0 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lofexidine', 'description': 'Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-16', 'size': 1798422, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-20T16:02', 'hasProtocol': True}, {'date': '2019-07-03', 'size': 445199, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-02T12:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All subjects, study personnel (including the Investigator, study coordinator(s), pharmacist/designee), and the Sponsor will be blinded to the identity of the study drug (active or placebo) administered to subjects.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'COVID pandemic and enrollment issues necessitating an adjustment to the study design.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2019-07-02', 'resultsFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-18', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment Emergent AEs and SAEs', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale', 'timeFrame': 'Day 1 through Day 28', 'description': 'The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a "yes" in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds "yes" to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral.'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'description': 'Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.'}, {'measure': 'Change in Pulse', 'timeFrame': 'Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Change in Clinical Opiate Withdrawal Scale (COWS)', 'timeFrame': 'Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28', 'description': 'The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48.'}, {'measure': 'Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)', 'timeFrame': 'Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'description': 'The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome.'}, {'measure': 'Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)', 'timeFrame': 'Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28', 'description': 'The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome.'}, {'measure': 'Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score', 'timeFrame': 'Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)', 'description': "MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug.\n\nSEVERITY OF ILLNESS:\n\n1. = No at all ill\n2. = Borderline ill\n3. = Mildly ill\n4. = Moderately ill\n5. = Markedly ill\n6. = Severely ill\n7. = Among the most extremely ill subjects\n\nSIDE EFFECTS INDEX:\n\n1. = None, study drug is producing no side effects\n2. = Do not significantly interfere with subject's functioning\n3. = Significantly interferes with subject's functioning\n4. = Outweighs therapeutic effect"}, {'measure': 'Modified Clinical Global Impression - Subject Version (MCGI-S)', 'timeFrame': 'Each scheduled evaluation (Day 1 through Day 28)', 'description': 'Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug.\n\nSEVERITY OF OPIATE WITHDRAWAL:\n\n1. = No opiate withdrawal symptoms\n2. = On the border between no to mild opiate withdrawal symptoms\n3. = Mild opiate withdrawal symptoms\n4. = Moderate opiate withdrawal symptoms\n5. = Marked opiate withdrawal symptoms\n6. = Severe opiate withdrawal symptoms\n7. = The most severe opiate withdrawal symptoms that I have ever had\n\nSIDE EFFECTS INDEX (Scale B):\n\n1. = None. The study drug has no side effects\n2. = The study drug has slight side effects, but it does NOT significantly interfere with my day to day activities\n3. = The study drug has moderate side effects, and it DOES significantly interfere with my day to day activities\n4. = The study drug has severe side effects, and these side effects are greater than the relief from opiate withdrawal symptoms that it provides'}, {'measure': 'Time to Study Drug Discontinuation', 'timeFrame': 'Day 1 through Day 28', 'description': 'Study day of participant discontinuation.'}, {'measure': 'Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale', 'timeFrame': 'Change from Baseline to EOS', 'description': 'The EQ-5D-5L is an instrument that evaluates preference for health status through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of which are rated on 5 levels of severity. Each dimension ranges from a minimum of "0 - I have no problems or I am not" to a maximum of "5 - I am unable to or I am extremely". The dimensions are averaged together for a single score and the change in average score from baseline is recorded.'}, {'measure': 'Change in Short Form Health Survey (SF-36) Scale', 'timeFrame': 'Change from baseline to End of Study, up to 55 days', 'description': 'The SF-36 consists of 36 questions that measure various aspects of physical and mental well-being. Precoded values are recorded for each question ranging from 0-100, with a high score defined as a more favorable health status. The items are then averaged together to create the 8 scale scores which are averaged together to create a scale.\n\nThe final value reported is the average change in the averaged scale scores from baseline to end of study.'}, {'measure': 'Change in Insomnia Severity Index (ISI)', 'timeFrame': 'Change from baseline to Days 15 and End of Study, up to 55 days', 'description': 'The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item on a scale 0 to 4 for each of the 7 items, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).'}, {'measure': 'Change in Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Change from End of Study to Baseline, up to 55 days', 'description': 'The HADS is a self-reported screening tool for anxiety and depression in nonpsychiatric clinical populations. Responses are based on the relative frequency of symptoms over the preceding week. The scale consists of 14 items, with a subscale of 7 questions for anxiety and 7 questions for depression. Patients rate each item in the subscales on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Possible scores range from 0 to 21 for each subscale. An analysis of scores on the 2 subscales supported the differentiation of each mood state into 4 ranges: non-cases (scores 0 to 7), mild cases (scores 8 to 10), moderate cases (scores 11 to 15), and severe cases (scores 16 or higher), with lower values being favorable. The subscales are then combined for a total score ranging from 0 to 42. Higher scores indicate greater levels of anxiety or depression. The value reported is the average change from baseline to End of Study.'}, {'measure': 'Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline through Follow-up (assessed daily)', 'description': 'A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain.\n\nThe format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.'}, {'measure': 'Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Day 1 through Day 28 (assessed daily)', 'description': 'The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.'}, {'measure': 'Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline through Day 51 (assessed daily)', 'description': 'The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.'}, {'measure': 'Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Day 1 through Day 28 (assessed daily)', 'description': 'The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.'}, {'measure': 'Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)', 'timeFrame': 'Baseline through Day 28'}, {'measure': 'Change in Daily Opioid Dose as a Percentage of the Baseline MED', 'timeFrame': 'Baseline through Day 28'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid Withdrawal Syndrome', 'OWS', 'Opioid taper', 'Opioid withdrawal', 'Opioid reduction', 'Stopping opioids', 'Opioid discontinuation', 'non-opioid pain management'], 'conditions': ['Opioid Withdrawal (Disorder)']}, 'descriptionModule': {'briefSummary': 'Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.', 'detailedDescription': 'This randomized, double-blind, placebo-controlled pilot study will evaluate the safety and effectiveness of LUCEMYRA in the treatment of opioid withdrawal during an opioid taper in subjects with chronic non-cancer pain.\n\nSubjects will begin a planned 14-day complete taper of their pre-study opioid medications and will be randomly assigned (1:1) to either LUCEMYRA or matching placebo. Study drug will be administered through the opioid taper and for 5 days after the opioid taper is completed. Study drug will then be tapered over a 4-day period for a total of approximately 21 days exposure to study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject can provide written informed consent.\n* Chronic non-cancer pain diagnosis such as low back pain, chronic neck pain, osteoarthritis, and prolonged post-surgical pain with daily pain for a minimum of 6 months.\n* Self-reported use of prescribed oral opioid medication(s) (tablets, pills or capsules) of at least 50 morphine mg equivalent (MME) but no higher than 240 mg MME daily or near daily (≥5 days per week) for at least 12 weeks and seeking to discontinue their opioid medication.\n* Willing to be treated with non-opioid treatments for pain (in addition to opioid being tapered) for duration of study.\n* Willing to abstain from alcohol use during the study.\n* Willing to partner with his or her pain physician on a subject-centered pain management plan during the study.\n* In generally good health, in the opinion of the Investigator, other than the underlying chronic pain syndrome\n* Women of childbearing potential must have a negative pregnancy test at Screening.\n* Non-pregnant, non-lactating women who are postmenopausal, naturally or surgically sterile, or who agree to use acceptable contraceptive methods throughout the course of the study.\n* Other criteria will be discussed in detail with potential subjects by Site Investigator\n\nExclusion Criteria:\n\n* Has a primary diagnosis of complex regional pain syndrome, central neuropathic pain, somatoform pain syndromes, acute nerve root compression, any acute or progressive infectious, inflammatory, or neurological process.\n* Taking methadone, buprenorphine, fentanyl rapid acting products, tapentadol, tramadol, butorphanol, meperidine, or levorphanol for any reason\n* Liver disease that requires medication or medical treatment, and/or AST or ALT levels greater than 3 x ULN.\n* Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment.\n* Has a diagnosis of epilepsy or history of seizures.\n* Cardiovascular abnormalities at Screening and before randomization (stable hypertension permitted)\n* Self-reported or evidence of opioid use disorder (OUD) or other substance use disorder within last 12 months\n* Any severe or unstable psychiatric disorder including post-traumatic stress disorder, schizophrenia, bipolar disorder, major depression, substance abuse, or suicidality as determined by the Investigator.\n* Subject answers "yes" to "suicidal ideation" in prior 24 months to any items 1 through 5 on the C-SSRS, or subject answers "yes" to any lifetime "suicidal behavior" item on the C-SSRS.\n* Any anticipated or scheduled surgery during the study period or within 30 days before Screening.\n* Other criteria will be discussed in detail with potential subjects by site Investigator'}, 'identificationModule': {'nctId': 'NCT04070157', 'acronym': 'TAPER', 'briefTitle': 'Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal', 'organization': {'class': 'INDUSTRY', 'fullName': 'USWM, LLC (dba US WorldMeds)'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects With Chronic Non-Cancer Pain', 'orgStudyIdInfo': {'id': 'USWM-LX1-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lofexidine', 'interventionNames': ['Drug: Lofexidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lofexidine', 'type': 'DRUG', 'otherNames': ['lofexidine hydrochloride', 'LUCEMYRA'], 'description': 'Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.', 'armGroupLabels': ['Lofexidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92870', 'city': 'Placentia', 'state': 'California', 'country': 'United States', 'facility': 'Westview Clinical Research, LLC', 'geoPoint': {'lat': 33.87224, 'lon': -117.87034}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Vitamed Research', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Gold Coast Research, LLC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '30044', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Clinical Research, LLC', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '83713', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Injury Care Research', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Global Scientific Innovations', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Integrated Clinical Trial Services, Inc.', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Neuroscience Research Center, LLC', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Otrimed Corporation (Otrimed Clinical Research Center)', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '14624', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27617', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Innovation Pain Therapies Clinic at Brier Creek', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'John Peppin, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'US WorldMeds Contract Medical Monitor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USWM, LLC (dba US WorldMeds)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}