Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-01 @ 7:34 AM
Study NCT ID:
NCT01738503
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '804-379-1090', 'title': 'Global Director, Clinical Development', 'organization': 'Indivior, Inc.'}, 'certainAgreement': {'otherDetails': "Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '- Subutex Only Days -14 to Day -1 - Groups 1-4 (no PET substudy): Days -14 up to Day 141 - Groups 5-6 (including PET substudy): Days -14 up to Day 316', 'eventGroups': [{'id': 'EG000', 'title': 'SUBUTEX Only', 'description': 'Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL and did not continue into the Treatment period.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 24, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 112 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Leukoyctosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 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'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 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35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Personality disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 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{'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SUBUTEX Only', 'description': 'Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL and did not continue into the Treatment period.'}, {'id': 'OG001', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG002', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG003', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG004', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG005', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG006', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': '>=1 TEAE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}]}, {'title': '>=1 TEAE related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': '>=1 Severe TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': '>=1 SAE other than death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Withdrew from study due to a TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days -14 to -1 (Subutex treatment), Days 1-316 (RBP-6000 treatment)', 'description': 'TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following outcomes: death; lifethreatening AE; hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis group'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: % Fluctuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '256.993', 'spread': '68.4944', 'groupId': 'OG000'}, {'value': '272.702', 'spread': '62.1424', 'groupId': 'OG001'}, {'value': '233.978', 'spread': '84.1776', 'groupId': 'OG002'}, {'value': '268.690', 'spread': '54.5116', 'groupId': 'OG003'}, {'value': '227.874', 'spread': '69.1437', 'groupId': 'OG004'}, {'value': '245.513', 'spread': '61.2524', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '213.664', 'spread': '50.7221', 'groupId': 'OG000'}, {'value': '175.068', 'spread': '69.0037', 'groupId': 'OG001'}, {'value': '168.963', 'spread': '31.8302', 'groupId': 'OG002'}, {'value': '140.924', 'spread': '39.3779', 'groupId': 'OG003'}, {'value': '135.433', 'spread': '31.4609', 'groupId': 'OG004'}, {'value': '107.909', 'spread': '33.9246', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '68.333', 'spread': '16.8729', 'groupId': 'OG000'}, {'value': '63.611', 'spread': '27.6839', 'groupId': 'OG001'}, {'value': '42.699', 'spread': '5.6645', 'groupId': 'OG002'}, {'value': '41.275', 'spread': '14.1786', 'groupId': 'OG003'}, {'value': '47.282', 'spread': '21.0395', 'groupId': 'OG004'}, {'value': '53.383', 'spread': '20.9467', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.597', 'groupId': 'OG004'}, {'value': '31.376', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '315.777', 'spread': '106.6237', 'groupId': 'OG000'}, {'value': '234.098', 'spread': '60.7481', 'groupId': 'OG001'}, {'value': '234.598', 'spread': '66.4979', 'groupId': 'OG002'}, {'value': '213.254', 'spread': '68.1754', 'groupId': 'OG003'}, {'value': '206.691', 'spread': '79.9858', 'groupId': 'OG004'}, {'value': '220.854', 'spread': '70.3346', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '152.755', 'spread': '75.3194', 'groupId': 'OG000'}, {'value': '95.140', 'spread': '20.9504', 'groupId': 'OG001'}, {'value': '75.633', 'spread': '17.3765', 'groupId': 'OG002'}, {'value': '77.067', 'spread': '21.4559', 'groupId': 'OG003'}, {'value': '75.202', 'spread': '28.4598', 'groupId': 'OG004'}, {'value': '83.695', 'spread': '12.8165', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '54.789', 'spread': '1.6355', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': '% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg\\*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': '% of average concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28.452', 'spread': '7.9415', 'groupId': 'OG000'}, {'value': '40.971', 'spread': '12.6823', 'groupId': 'OG001'}, {'value': '63.019', 'spread': '16.4068', 'groupId': 'OG002'}, {'value': '30.029', 'spread': '12.8676', 'groupId': 'OG003'}, {'value': '46.681', 'spread': '11.8403', 'groupId': 'OG004'}, {'value': '46.628', 'spread': '23.2554', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 1 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '46.855', 'spread': '11.5533', 'groupId': 'OG000'}, {'value': '72.453', 'spread': '25.4451', 'groupId': 'OG001'}, {'value': '109.029', 'spread': '30.2598', 'groupId': 'OG002'}, {'value': '62.395', 'spread': '20.3054', 'groupId': 'OG003'}, {'value': '104.868', 'spread': '22.6943', 'groupId': 'OG004'}, {'value': '164.511', 'spread': '47.8237', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 4 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '69.845', 'spread': '24.4947', 'groupId': 'OG000'}, {'value': '113.347', 'spread': '29.7760', 'groupId': 'OG001'}, {'value': '185.535', 'spread': '48.2330', 'groupId': 'OG002'}, {'value': '98.566', 'spread': '17.8092', 'groupId': 'OG003'}, {'value': '172.421', 'spread': '29.3259', 'groupId': 'OG004'}, {'value': '381.729', 'spread': '81.4365', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 6 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '216.540', 'spread': '48.7904', 'groupId': 'OG004'}, {'value': '320.159', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '208.013', 'spread': '43.2691', 'groupId': 'OG000'}, {'value': '395.450', 'spread': '115.3659', 'groupId': 'OG001'}, {'value': '541.226', 'spread': '193.6220', 'groupId': 'OG002'}, {'value': '368.925', 'spread': '137.2231', 'groupId': 'OG003'}, {'value': '648.344', 'spread': '217.2051', 'groupId': 'OG004'}, {'value': '926.110', 'spread': '285.6452', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '596.568', 'spread': '227.2414', 'groupId': 'OG000'}, {'value': '1142.046', 'spread': '380.1915', 'groupId': 'OG001'}, {'value': '1807.403', 'spread': '441.0377', 'groupId': 'OG002'}, {'value': '1073.201', 'spread': '240.7532', 'groupId': 'OG003'}, {'value': '1859.204', 'spread': '477.7799', 'groupId': 'OG004'}, {'value': '3426.313', 'spread': '672.5864', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2209.11', 'groupId': 'OG004'}, {'value': '3460.459', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1 (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.922', 'spread': '6.4450', 'groupId': 'OG000'}, {'value': '36.981', 'spread': '14.3565', 'groupId': 'OG001'}, {'value': '55.291', 'spread': '17.0179', 'groupId': 'OG002'}, {'value': '31.747', 'spread': '13.2180', 'groupId': 'OG003'}, {'value': '50.034', 'spread': '11.4899', 'groupId': 'OG004'}, {'value': '85.090', 'spread': '28.7163', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '246.650', 'spread': '54.9881', 'groupId': 'OG000'}, {'value': '461.366', 'spread': '142.2166', 'groupId': 'OG001'}, {'value': '642.010', 'spread': '228.0284', 'groupId': 'OG002'}, {'value': '413.438', 'spread': '133.0365', 'groupId': 'OG003'}, {'value': '756.053', 'spread': '233.8099', 'groupId': 'OG004'}, {'value': '1268.012', 'spread': '389.6719', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4 (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.250', 'spread': '14.5405', 'groupId': 'OG000'}, {'value': '56.231', 'spread': '15.6411', 'groupId': 'OG001'}, {'value': '91.197', 'spread': '27.4005', 'groupId': 'OG002'}, {'value': '47.633', 'spread': '9.6147', 'groupId': 'OG003'}, {'value': '81.417', 'spread': '18.3829', 'groupId': 'OG004'}, {'value': '178.109', 'spread': '43.2176', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '667.611', 'spread': '254.2712', 'groupId': 'OG000'}, {'value': '1272.047', 'spread': '434.1013', 'groupId': 'OG001'}, {'value': '1932.068', 'spread': '455.1540', 'groupId': 'OG002'}, {'value': '1275.098', 'spread': '252.8500', 'groupId': 'OG003'}, {'value': '2051.989', 'spread': '466.6935', 'groupId': 'OG004'}, {'value': '3230.873', 'spread': '430.6718', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6 (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '155.779', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2585.976', 'spread': '276.6695', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Average Plasma Concentration (Cavg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.186', 'spread': '0.3309', 'groupId': 'OG000'}, {'value': '1.707', 'spread': '0.5284', 'groupId': 'OG001'}, {'value': '2.626', 'spread': '0.6836', 'groupId': 'OG002'}, {'value': '1.251', 'spread': '0.5362', 'groupId': 'OG003'}, {'value': '1.945', 'spread': '0.4933', 'groupId': 'OG004'}, {'value': '1.943', 'spread': '0.9690', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.333', 'spread': '0.0693', 'groupId': 'OG000'}, {'value': '0.634', 'spread': '0.1849', 'groupId': 'OG001'}, {'value': '0.867', 'spread': '0.3103', 'groupId': 'OG002'}, {'value': '0.591', 'spread': '0.2199', 'groupId': 'OG003'}, {'value': '1.039', 'spread': '0.3481', 'groupId': 'OG004'}, {'value': '1.484', 'spread': '0.4578', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.954', 'spread': '0.3642', 'groupId': 'OG000'}, {'value': '1.830', 'spread': '0.6093', 'groupId': 'OG001'}, {'value': '2.896', 'spread': '0.7068', 'groupId': 'OG002'}, {'value': '1.720', 'spread': '0.3858', 'groupId': 'OG003'}, {'value': '2.979', 'spread': '0.7657', 'groupId': 'OG004'}, {'value': '5.491', 'spread': '1.0779', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.540', 'groupId': 'OG004'}, {'value': '5.546', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.367', 'spread': '0.0818', 'groupId': 'OG000'}, {'value': '0.687', 'spread': '0.2116', 'groupId': 'OG001'}, {'value': '0.955', 'spread': '0.3393', 'groupId': 'OG002'}, {'value': '0.615', 'spread': '0.1980', 'groupId': 'OG003'}, {'value': '1.125', 'spread': '0.3331', 'groupId': 'OG004'}, {'value': '1.887', 'spread': '0.5799', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.993', 'spread': '0.3784', 'groupId': 'OG000'}, {'value': '1.893', 'spread': '0.6460', 'groupId': 'OG001'}, {'value': '2.875', 'spread': '0.6773', 'groupId': 'OG002'}, {'value': '1.897', 'spread': '0.3763', 'groupId': 'OG003'}, {'value': '3.054', 'spread': '0.6945', 'groupId': 'OG004'}, {'value': '4.808', 'spread': '0.6409', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.848', 'spread': '0.4117', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.521', 'spread': '1.0407', 'groupId': 'OG000'}, {'value': '5.350', 'spread': '1.7340', 'groupId': 'OG001'}, {'value': '7.571', 'spread': '3.0928', 'groupId': 'OG002'}, {'value': '3.964', 'spread': '1.9131', 'groupId': 'OG003'}, {'value': '5.260', 'spread': '1.5595', 'groupId': 'OG004'}, {'value': '5.813', 'spread': '3.4264', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 1 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.352', 'spread': '0.4641', 'groupId': 'OG000'}, {'value': '1.916', 'spread': '0.6773', 'groupId': 'OG001'}, {'value': '2.755', 'spread': '0.7630', 'groupId': 'OG002'}, {'value': '1.686', 'spread': '0.6200', 'groupId': 'OG003'}, {'value': '2.861', 'spread': '0.7136', 'groupId': 'OG004'}, {'value': '4.817', 'spread': '1.4337', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 4 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.085', 'spread': '1.4381', 'groupId': 'OG000'}, {'value': '2.958', 'spread': '0.9624', 'groupId': 'OG001'}, {'value': '4.526', 'spread': '1.3078', 'groupId': 'OG002'}, {'value': '2.549', 'spread': '0.4797', 'groupId': 'OG003'}, {'value': '4.404', 'spread': '0.9231', 'groupId': 'OG004'}, {'value': '9.637', 'spread': '2.3409', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 6 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.015', 'spread': '0.8980', 'groupId': 'OG004'}, {'value': '7.140', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.853', 'spread': '0.2687', 'groupId': 'OG000'}, {'value': '1.518', 'spread': '0.8167', 'groupId': 'OG001'}, {'value': '2.018', 'spread': '0.6205', 'groupId': 'OG002'}, {'value': '1.174', 'spread': '0.3432', 'groupId': 'OG003'}, {'value': '2.112', 'spread': '0.6935', 'groupId': 'OG004'}, {'value': '2.975', 'spread': '0.8839', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.384', 'spread': '0.4767', 'groupId': 'OG000'}, {'value': '2.590', 'spread': '0.8536', 'groupId': 'OG001'}, {'value': '3.776', 'spread': '0.8970', 'groupId': 'OG002'}, {'value': '2.211', 'spread': '0.3824', 'groupId': 'OG003'}, {'value': '3.780', 'spread': '0.6646', 'groupId': 'OG004'}, {'value': '7.452', 'spread': '1.6913', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.650', 'spread': '0.8910', 'groupId': 'OG004'}, {'value': '6.550', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.352', 'spread': '0.4641', 'groupId': 'OG000'}, {'value': '2.023', 'spread': '0.8251', 'groupId': 'OG001'}, {'value': '2.732', 'spread': '0.7866', 'groupId': 'OG002'}, {'value': '1.686', 'spread': '0.6200', 'groupId': 'OG003'}, {'value': '2.861', 'spread': '0.7136', 'groupId': 'OG004'}, {'value': '4.817', 'spread': '1.4337', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.085', 'spread': '1.4381', 'groupId': 'OG000'}, {'value': '3.066', 'spread': '0.8658', 'groupId': 'OG001'}, {'value': '4.526', 'spread': '1.3078', 'groupId': 'OG002'}, {'value': '2.554', 'spread': '0.4775', 'groupId': 'OG003'}, {'value': '4.404', 'spread': '0.9231', 'groupId': 'OG004'}, {'value': '9.637', 'spread': '2.3409', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.015', 'spread': '0.8980', 'groupId': 'OG004'}, {'value': '7.140', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Maximum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.524', 'spread': '0.2212', 'groupId': 'OG000'}, {'value': '0.806', 'spread': '0.3638', 'groupId': 'OG001'}, {'value': '1.385', 'spread': '0.4806', 'groupId': 'OG002'}, {'value': '0.568', 'spread': '0.2367', 'groupId': 'OG003'}, {'value': '0.920', 'spread': '0.2800', 'groupId': 'OG004'}, {'value': '0.927', 'spread': '0.4667', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.206', 'spread': '0.0556', 'groupId': 'OG000'}, {'value': '0.388', 'spread': '0.1145', 'groupId': 'OG001'}, {'value': '0.600', 'spread': '0.2623', 'groupId': 'OG002'}, {'value': '0.388', 'spread': '0.1554', 'groupId': 'OG003'}, {'value': '0.714', 'spread': '0.2315', 'groupId': 'OG004'}, {'value': '1.244', 'spread': '0.4455', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.791', 'spread': '0.3017', 'groupId': 'OG000'}, {'value': '1.434', 'spread': '0.3706', 'groupId': 'OG001'}, {'value': '2.575', 'spread': '0.6439', 'groupId': 'OG002'}, {'value': '1.552', 'spread': '0.3448', 'groupId': 'OG003'}, {'value': '2.498', 'spread': '0.7269', 'groupId': 'OG004'}, {'value': '4.600', 'spread': '0.7743', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.325', 'spread': '0.1485', 'groupId': 'OG004'}, {'value': '4.810', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.206', 'spread': '0.0556', 'groupId': 'OG000'}, {'value': '0.375', 'spread': '0.1001', 'groupId': 'OG001'}, {'value': '0.589', 'spread': '0.2522', 'groupId': 'OG002'}, {'value': '0.410', 'spread': '0.1955', 'groupId': 'OG003'}, {'value': '0.700', 'spread': '0.2196', 'groupId': 'OG004'}, {'value': '0.836', 'spread': '0.3756', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.557', 'spread': '0.1559', 'groupId': 'OG000'}, {'value': '1.263', 'spread': '0.3574', 'groupId': 'OG001'}, {'value': '2.121', 'spread': '0.4689', 'groupId': 'OG002'}, {'value': '1.180', 'spread': '0.2803', 'groupId': 'OG003'}, {'value': '2.256', 'spread': '0.6472', 'groupId': 'OG004'}, {'value': '4.043', 'spread': '0.6936', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.910', 'spread': '0.7354', 'groupId': 'OG004'}, {'value': '4.290', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Minimum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Swing of Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '656.884', 'spread': '303.7135', 'groupId': 'OG000'}, {'value': '665.742', 'spread': '314.6530', 'groupId': 'OG001'}, {'value': '493.475', 'spread': '273.1229', 'groupId': 'OG002'}, {'value': '597.543', 'spread': '136.8431', 'groupId': 'OG003'}, {'value': '500.322', 'spread': '183.7474', 'groupId': 'OG004'}, {'value': '534.280', 'spread': '217.8816', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '332.132', 'spread': '127.9638', 'groupId': 'OG000'}, {'value': '295.987', 'spread': '229.0036', 'groupId': 'OG001'}, {'value': '253.417', 'spread': '61.2944', 'groupId': 'OG002'}, {'value': '223.388', 'spread': '94.3116', 'groupId': 'OG003'}, {'value': '197.895', 'spread': '49.3822', 'groupId': 'OG004'}, {'value': '147.463', 'spread': '66.0341', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '79.731', 'spread': '27.3175', 'groupId': 'OG000'}, {'value': '84.772', 'spread': '48.3724', 'groupId': 'OG001'}, {'value': '47.479', 'spread': '10.5422', 'groupId': 'OG002'}, {'value': '44.874', 'spread': '18.5656', 'groupId': 'OG003'}, {'value': '57.889', 'spread': '30.3975', 'groupId': 'OG004'}, {'value': '61.481', 'spread': '24.0339', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '39.390', 'spread': '20.5703', 'groupId': 'OG004'}, {'value': '36.175', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '586.788', 'spread': '219.9900', 'groupId': 'OG000'}, {'value': '440.102', 'spread': '200.5223', 'groupId': 'OG001'}, {'value': '399.355', 'spread': '140.2055', 'groupId': 'OG002'}, {'value': '350.591', 'spread': '158.0245', 'groupId': 'OG003'}, {'value': '336.666', 'spread': '149.7124', 'groupId': 'OG004'}, {'value': '548.179', 'spread': '272.0431', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '279.713', 'spread': '214.1821', 'groupId': 'OG000'}, {'value': '147.264', 'spread': '48.3533', 'groupId': 'OG001'}, {'value': '112.812', 'spread': '32.8955', 'groupId': 'OG002'}, {'value': '120.236', 'spread': '28.1402', 'groupId': 'OG003'}, {'value': '103.271', 'spread': '43.4914', 'groupId': 'OG004'}, {'value': '138.783', 'spread': '47.6186', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '73.993', 'spread': '13.1102', 'groupId': 'OG004'}, {'value': '66.434', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'The swing of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.\n\nCmax=maximum plasma concentration Cmin=minimum plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'percentage of Cmin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.017', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.117', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '2.000', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '2.000', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '2.13'}, {'value': '2.000', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '2.00'}]}]}, {'title': 'Initial Burst: Injection 1 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.000', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '20.05'}, {'value': '20.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '20.000', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '48.00'}, {'value': '20.000', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '20.000', 'groupId': 'OG004', 'lowerLimit': '6.00', 'upperLimit': '48.00'}, {'value': '20.000', 'groupId': 'OG005', 'lowerLimit': '4.00', 'upperLimit': '32.00'}]}]}, {'title': 'Initial Burst: Injection 4 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.000', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '24.00'}, {'value': '20.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '30.07'}, {'value': '20.083', 'groupId': 'OG002', 'lowerLimit': '8.00', 'upperLimit': '30.08'}, {'value': '24.000', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '48.03'}, {'value': '24.000', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '24.000', 'groupId': 'OG005', 'lowerLimit': '4.00', 'upperLimit': '36.00'}]}]}, {'title': 'Initial Burst: Injection 6 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.000', 'groupId': 'OG004', 'lowerLimit': '24.00', 'upperLimit': '24.00'}, {'value': '24.350', 'groupId': 'OG005', 'lowerLimit': '24.35', 'upperLimit': '24.35'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG001', 'lowerLimit': '48.00', 'upperLimit': '457.15'}, {'value': '48.000', 'groupId': 'OG002', 'lowerLimit': '48.00', 'upperLimit': '49.10'}, {'value': '48.000', 'groupId': 'OG003', 'lowerLimit': '48.00', 'upperLimit': '48.07'}, {'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '48.07'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '532.55'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '48.07'}, {'value': '48.000', 'groupId': 'OG001', 'lowerLimit': '48.00', 'upperLimit': '315.95'}, {'value': '48.000', 'groupId': 'OG002', 'lowerLimit': '48.00', 'upperLimit': '49.12'}, {'value': '48.000', 'groupId': 'OG003', 'lowerLimit': '48.00', 'upperLimit': '629.07'}, {'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '485.17'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '436.75'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '48.00'}]}]}, {'title': 'Overall: Injection 1 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.000', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '20.05'}, {'value': '20.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '414.17'}, {'value': '20.000', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '30.00'}, {'value': '20.000', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '20.000', 'groupId': 'OG004', 'lowerLimit': '6.00', 'upperLimit': '48.00'}, {'value': '20.000', 'groupId': 'OG005', 'lowerLimit': '4.00', 'upperLimit': '32.00'}]}]}, {'title': 'Overall: Injection 4 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.000', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '24.00'}, {'value': '20.000', 'groupId': 'OG001', 'lowerLimit': '12.00', 'upperLimit': '315.95'}, {'value': '20.083', 'groupId': 'OG002', 'lowerLimit': '8.00', 'upperLimit': '30.08'}, {'value': '24.000', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '529.83'}, {'value': '24.000', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '24.000', 'groupId': 'OG005', 'lowerLimit': '4.00', 'upperLimit': '36.00'}]}]}, {'title': 'Overall: Injection 6 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.000', 'groupId': 'OG004', 'lowerLimit': '24.00', 'upperLimit': '24.00'}, {'value': '24.350', 'groupId': 'OG005', 'lowerLimit': '24.35', 'upperLimit': '24.35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Results are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.580', 'spread': '0.9662', 'groupId': 'OG000'}, {'value': '2.738', 'spread': '0.5104', 'groupId': 'OG001'}, {'value': '3.456', 'spread': '0.9296', 'groupId': 'OG002'}, {'value': '3.379', 'spread': '0.9182', 'groupId': 'OG003'}, {'value': '2.837', 'spread': '0.8660', 'groupId': 'OG004'}, {'value': '3.573', 'spread': '0.5660', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants with data at both timepoints'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.380', 'spread': '0.4610', 'groupId': 'OG000'}, {'value': '1.560', 'spread': '0.5322', 'groupId': 'OG001'}, {'value': '1.766', 'spread': '0.5407', 'groupId': 'OG002'}, {'value': '1.729', 'spread': '0.6106', 'groupId': 'OG003'}, {'value': '1.559', 'spread': '0.2642', 'groupId': 'OG004'}, {'value': '1.908', 'spread': '0.4411', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants with data at both timepoints'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '85.543', 'spread': '34.6133', 'groupId': 'OG000'}, {'value': '85.043', 'spread': '21.9189', 'groupId': 'OG001'}, {'value': '105.155', 'spread': '23.4377', 'groupId': 'OG002'}, {'value': '87.404', 'spread': '21.0436', 'groupId': 'OG003'}, {'value': '105.390', 'spread': '29.3714', 'groupId': 'OG004'}, {'value': '80.860', 'spread': '15.8555', 'groupId': 'OG005'}]}]}, {'title': 'Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '77.749', 'spread': '8.3342', 'groupId': 'OG004'}, {'value': '79.777', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 85-113, 141-169', 'description': 'Apparent clearance at steady-state (CLss/F) = Dose / AUCtau (tau was 28 days).', 'unitOfMeasure': 'L/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '2280.295', 'spread': '17.4444', 'groupId': 'OG000'}, {'value': '3521.376', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 85-113', 'description': 'Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 (last injection) in subjects not participating in PET imaging sub-study only as:\n\n(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants whose data met requirements.'}, {'type': 'PRIMARY', 'title': 'Buprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '550.329', 'spread': '36.7325', 'groupId': 'OG000'}, {'value': '138.238', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 85-113', 'description': 'The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants whose data met requirements.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: % Fluctuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '69.798', 'spread': '21.5137', 'groupId': 'OG000'}, {'value': '94.132', 'spread': '43.7842', 'groupId': 'OG001'}, {'value': '79.225', 'spread': '19.2173', 'groupId': 'OG002'}, {'value': '82.834', 'spread': '29.0182', 'groupId': 'OG003'}, {'value': '89.832', 'spread': '31.3881', 'groupId': 'OG004'}, {'value': '71.213', 'spread': '18.7721', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '577.952', 'spread': '119.5038', 'groupId': 'OG000'}, {'value': '475.800', 'spread': '149.9103', 'groupId': 'OG001'}, {'value': '504.540', 'spread': '170.1714', 'groupId': 'OG002'}, {'value': '403.009', 'spread': '115.9346', 'groupId': 'OG003'}, {'value': '407.217', 'spread': '160.6071', 'groupId': 'OG004'}, {'value': '354.764', 'spread': '136.5715', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '114.801', 'spread': '33.7254', 'groupId': 'OG000'}, {'value': '127.106', 'spread': '64.0505', 'groupId': 'OG001'}, {'value': '110.567', 'spread': '42.0264', 'groupId': 'OG002'}, {'value': '77.455', 'spread': '24.7664', 'groupId': 'OG003'}, {'value': '101.898', 'spread': '28.8808', 'groupId': 'OG004'}, {'value': '83.579', 'spread': '18.6265', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '91.763', 'groupId': 'OG004'}, {'value': '242.246', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '612.998', 'spread': '141.7474', 'groupId': 'OG000'}, {'value': '502.856', 'spread': '101.2508', 'groupId': 'OG001'}, {'value': '685.962', 'spread': '195.9687', 'groupId': 'OG002'}, {'value': '497.361', 'spread': '138.6539', 'groupId': 'OG003'}, {'value': '609.481', 'spread': '145.8650', 'groupId': 'OG004'}, {'value': '468.074', 'spread': '186.0526', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '128.273', 'spread': '31.6391', 'groupId': 'OG000'}, {'value': '131.080', 'spread': '57.4294', 'groupId': 'OG001'}, {'value': '127.005', 'spread': '37.8487', 'groupId': 'OG002'}, {'value': '95.960', 'spread': '18.6296', 'groupId': 'OG003'}, {'value': '131.650', 'spread': '43.6260', 'groupId': 'OG004'}, {'value': '102.192', 'spread': '12.2405', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.048', 'spread': '7.4553', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': '% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg\\*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': '% of average concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42.536', 'spread': '17.9975', 'groupId': 'OG000'}, {'value': '72.339', 'spread': '35.1371', 'groupId': 'OG001'}, {'value': '134.739', 'spread': '40.4214', 'groupId': 'OG002'}, {'value': '49.312', 'spread': '22.6050', 'groupId': 'OG003'}, {'value': '65.558', 'spread': '25.0632', 'groupId': 'OG004'}, {'value': '98.407', 'spread': '81.7085', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 1 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '60.834', 'spread': '27.8301', 'groupId': 'OG000'}, {'value': '98.705', 'spread': '54.0709', 'groupId': 'OG001'}, {'value': '180.685', 'spread': '53.1546', 'groupId': 'OG002'}, {'value': '69.878', 'spread': '26.1289', 'groupId': 'OG003'}, {'value': '131.277', 'spread': '82.0351', 'groupId': 'OG004'}, {'value': '148.016', 'spread': '97.0872', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 4 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15.435', 'spread': '8.0734', 'groupId': 'OG000'}, {'value': '29.401', 'spread': '16.3007', 'groupId': 'OG001'}, {'value': '50.185', 'spread': '19.6558', 'groupId': 'OG002'}, {'value': '30.755', 'spread': '11.0344', 'groupId': 'OG003'}, {'value': '45.941', 'spread': '24.8979', 'groupId': 'OG004'}, {'value': '101.888', 'spread': '39.8768', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 6 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '59.352', 'spread': '2.2741', 'groupId': 'OG004'}, {'value': '90.719', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '122.265', 'spread': '43.4215', 'groupId': 'OG000'}, {'value': '209.679', 'spread': '85.5994', 'groupId': 'OG001'}, {'value': '384.101', 'spread': '133.4394', 'groupId': 'OG002'}, {'value': '197.483', 'spread': '59.5501', 'groupId': 'OG003'}, {'value': '295.342', 'spread': '142.3582', 'groupId': 'OG004'}, {'value': '513.577', 'spread': '322.8520', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '166.360', 'spread': '82.1264', 'groupId': 'OG000'}, {'value': '523.076', 'spread': '431.7284', 'groupId': 'OG001'}, {'value': '519.103', 'spread': '236.8835', 'groupId': 'OG002'}, {'value': '410.621', 'spread': '146.1564', 'groupId': 'OG003'}, {'value': '550.225', 'spread': '215.6699', 'groupId': 'OG004'}, {'value': '1208.505', 'spread': '463.9637', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '537.212', 'groupId': 'OG004'}, {'value': '592.199', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1 (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '32.465', 'spread': '14.2953', 'groupId': 'OG000'}, {'value': '52.878', 'spread': '28.0773', 'groupId': 'OG001'}, {'value': '99.040', 'spread': '30.8899', 'groupId': 'OG002'}, {'value': '37.446', 'spread': '15.9959', 'groupId': 'OG003'}, {'value': '68.660', 'spread': '38.8033', 'groupId': 'OG004'}, {'value': '80.525', 'spread': '51.3662', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '181.912', 'spread': '81.6100', 'groupId': 'OG000'}, {'value': '343.357', 'spread': '150.5029', 'groupId': 'OG001'}, {'value': '541.539', 'spread': '176.5176', 'groupId': 'OG002'}, {'value': '261.745', 'spread': '81.3672', 'groupId': 'OG003'}, {'value': '426.283', 'spread': '224.4167', 'groupId': 'OG004'}, {'value': '688.487', 'spread': '429.8748', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4 (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.274', 'spread': '2.7973', 'groupId': 'OG000'}, {'value': '15.199', 'spread': '11.7793', 'groupId': 'OG001'}, {'value': '22.870', 'spread': '9.3521', 'groupId': 'OG002'}, {'value': '13.807', 'spread': '5.3021', 'groupId': 'OG003'}, {'value': '16.301', 'spread': '6.4778', 'groupId': 'OG004'}, {'value': '43.722', 'spread': '16.4542', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '182.405', 'spread': '91.5308', 'groupId': 'OG000'}, {'value': '557.707', 'spread': '471.2095', 'groupId': 'OG001'}, {'value': '570.958', 'spread': '254.4439', 'groupId': 'OG002'}, {'value': '452.892', 'spread': '152.6941', 'groupId': 'OG003'}, {'value': '673.245', 'spread': '167.1460', 'groupId': 'OG004'}, {'value': '658.609', 'spread': '159.7954', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6 (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '37.093', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '814.570', 'spread': '306.2799', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Average Plasma Concentration (Cavg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.772', 'spread': '0.7499', 'groupId': 'OG000'}, {'value': '3.014', 'spread': '1.4640', 'groupId': 'OG001'}, {'value': '5.614', 'spread': '1.6842', 'groupId': 'OG002'}, {'value': '2.055', 'spread': '0.9419', 'groupId': 'OG003'}, {'value': '2.732', 'spread': '1.0443', 'groupId': 'OG004'}, {'value': '4.100', 'spread': '3.4045', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.196', 'spread': '0.0696', 'groupId': 'OG000'}, {'value': '0.336', 'spread': '0.1372', 'groupId': 'OG001'}, {'value': '0.616', 'spread': '0.2138', 'groupId': 'OG002'}, {'value': '0.316', 'spread': '0.0954', 'groupId': 'OG003'}, {'value': '0.473', 'spread': '0.2281', 'groupId': 'OG004'}, {'value': '0.823', 'spread': '0.5174', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.267', 'spread': '0.1316', 'groupId': 'OG000'}, {'value': '0.838', 'spread': '0.6919', 'groupId': 'OG001'}, {'value': '0.832', 'spread': '0.3796', 'groupId': 'OG002'}, {'value': '0.658', 'spread': '0.2342', 'groupId': 'OG003'}, {'value': '0.882', 'spread': '0.3456', 'groupId': 'OG004'}, {'value': '1.937', 'spread': '0.7435', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.861', 'groupId': 'OG004'}, {'value': '0.949', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.271', 'spread': '0.1214', 'groupId': 'OG000'}, {'value': '0.511', 'spread': '0.2240', 'groupId': 'OG001'}, {'value': '0.806', 'spread': '0.2627', 'groupId': 'OG002'}, {'value': '0.390', 'spread': '0.1211', 'groupId': 'OG003'}, {'value': '0.634', 'spread': '0.3340', 'groupId': 'OG004'}, {'value': '1.025', 'spread': '0.6397', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.271', 'spread': '0.1362', 'groupId': 'OG000'}, {'value': '0.830', 'spread': '0.7012', 'groupId': 'OG001'}, {'value': '0.850', 'spread': '0.3786', 'groupId': 'OG002'}, {'value': '0.674', 'spread': '0.2272', 'groupId': 'OG003'}, {'value': '1.002', 'spread': '0.2487', 'groupId': 'OG004'}, {'value': '0.980', 'spread': '0.2378', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.212', 'spread': '0.4558', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.559', 'spread': '1.0590', 'groupId': 'OG000'}, {'value': '4.941', 'spread': '2.5414', 'groupId': 'OG001'}, {'value': '8.515', 'spread': '2.3854', 'groupId': 'OG002'}, {'value': '3.268', 'spread': '1.6946', 'groupId': 'OG003'}, {'value': '5.268', 'spread': '1.9934', 'groupId': 'OG004'}, {'value': '5.820', 'spread': '4.7007', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 1 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.674', 'spread': '0.7498', 'groupId': 'OG000'}, {'value': '2.704', 'spread': '1.3861', 'groupId': 'OG001'}, {'value': '5.335', 'spread': '1.7751', 'groupId': 'OG002'}, {'value': '1.965', 'spread': '0.7884', 'groupId': 'OG003'}, {'value': '3.878', 'spread': '2.1658', 'groupId': 'OG004'}, {'value': '4.496', 'spread': '3.0242', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 4 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.462', 'spread': '0.2894', 'groupId': 'OG000'}, {'value': '0.966', 'spread': '0.5829', 'groupId': 'OG001'}, {'value': '1.343', 'spread': '0.4299', 'groupId': 'OG002'}, {'value': '0.799', 'spread': '0.2673', 'groupId': 'OG003'}, {'value': '1.305', 'spread': '0.5998', 'groupId': 'OG004'}, {'value': '2.769', 'spread': '1.2538', 'groupId': 'OG005'}]}]}, {'title': 'Initial Burst: Injection 6 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.885', 'spread': '0.6152', 'groupId': 'OG004'}, {'value': '2.620', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.165', 'spread': '0.5506', 'groupId': 'OG000'}, {'value': '1.904', 'spread': '1.0984', 'groupId': 'OG001'}, {'value': '3.201', 'spread': '1.1802', 'groupId': 'OG002'}, {'value': '1.320', 'spread': '0.4278', 'groupId': 'OG003'}, {'value': '2.203', 'spread': '1.4464', 'groupId': 'OG004'}, {'value': '3.212', 'spread': '2.8810', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.464', 'spread': '0.2903', 'groupId': 'OG000'}, {'value': '1.423', 'spread': '1.1714', 'groupId': 'OG001'}, {'value': '1.387', 'spread': '0.4635', 'groupId': 'OG002'}, {'value': '0.926', 'spread': '0.3107', 'groupId': 'OG003'}, {'value': '1.420', 'spread': '0.7152', 'groupId': 'OG004'}, {'value': '2.710', 'spread': '1.1727', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.885', 'spread': '0.6152', 'groupId': 'OG004'}, {'value': '2.620', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.698', 'spread': '0.7748', 'groupId': 'OG000'}, {'value': '2.753', 'spread': '1.4051', 'groupId': 'OG001'}, {'value': '5,572', 'spread': '1.9291', 'groupId': 'OG002'}, {'value': '1.977', 'spread': '0.7880', 'groupId': 'OG003'}, {'value': '3.989', 'spread': '2.3167', 'groupId': 'OG004'}, {'value': '4.555', 'spread': '3.1010', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.474', 'spread': '0.2849', 'groupId': 'OG000'}, {'value': '1.431', 'spread': '1.1652', 'groupId': 'OG001'}, {'value': '1.456', 'spread': '0.4572', 'groupId': 'OG002'}, {'value': '0.929', 'spread': '0.3058', 'groupId': 'OG003'}, {'value': '1.539', 'spread': '0.6406', 'groupId': 'OG004'}, {'value': '2.769', 'spread': '1.2538', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.885', 'spread': '0.6152', 'groupId': 'OG004'}, {'value': '2.620', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Maximum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.361', 'spread': '0.6010', 'groupId': 'OG000'}, {'value': '2.342', 'spread': '1.2494', 'groupId': 'OG001'}, {'value': '4.287', 'spread': '1.3351', 'groupId': 'OG002'}, {'value': '1.582', 'spread': '0.7554', 'groupId': 'OG003'}, {'value': '2.482', 'spread': '1.1788', 'groupId': 'OG004'}, {'value': '2.923', 'spread': '2.1949', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.057', 'spread': '0.0202', 'groupId': 'OG000'}, {'value': '0.099', 'spread': '0.0447', 'groupId': 'OG001'}, {'value': '0.162', 'spread': '0.0827', 'groupId': 'OG002'}, {'value': '0.119', 'spread': '0.0592', 'groupId': 'OG003'}, {'value': '0.177', 'spread': '0.0919', 'groupId': 'OG004'}, {'value': '0.258', 'spread': '0.1289', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.165', 'spread': '0.0708', 'groupId': 'OG000'}, {'value': '0.432', 'spread': '0.4181', 'groupId': 'OG001'}, {'value': '0.548', 'spread': '0.2119', 'groupId': 'OG002'}, {'value': '0.439', 'spread': '0.1550', 'groupId': 'OG003'}, {'value': '0.587', 'spread': '0.3165', 'groupId': 'OG004'}, {'value': '1.234', 'spread': '0.5279', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.895', 'spread': '0.3323', 'groupId': 'OG004'}, {'value': '0.321', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.057', 'spread': '0.0202', 'groupId': 'OG000'}, {'value': '0.098', 'spread': '0.0441', 'groupId': 'OG001'}, {'value': '0.162', 'spread': '0.0827', 'groupId': 'OG002'}, {'value': '0.152', 'spread': '0.1427', 'groupId': 'OG003'}, {'value': '0.177', 'spread': '0.0919', 'groupId': 'OG004'}, {'value': '0.301', 'spread': '0.2180', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.125', 'spread': '0.0539', 'groupId': 'OG000'}, {'value': '0.327', 'spread': '0.2592', 'groupId': 'OG001'}, {'value': '0.461', 'spread': '0.2292', 'groupId': 'OG002'}, {'value': '0.349', 'spread': '0.1609', 'groupId': 'OG003'}, {'value': '0.459', 'spread': '0.2191', 'groupId': 'OG004'}, {'value': '0.982', 'spread': '0.3281', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.728', 'spread': '0.0962', 'groupId': 'OG004'}, {'value': '0.281', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Minimum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Swing of Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '93.472', 'spread': '33.4835', 'groupId': 'OG000'}, {'value': '130.823', 'spread': '74.2916', 'groupId': 'OG001'}, {'value': '102.059', 'spread': '29.6116', 'groupId': 'OG002'}, {'value': '109.416', 'spread': '42.1913', 'groupId': 'OG003'}, {'value': '124.601', 'spread': '45.9786', 'groupId': 'OG004'}, {'value': '101.558', 'spread': '38.5511', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1993.328', 'spread': '1002.6237', 'groupId': 'OG000'}, {'value': '1871.238', 'spread': '933.9815', 'groupId': 'OG001'}, {'value': '2531.386', 'spread': '1775.8060', 'groupId': 'OG002'}, {'value': '1188.490', 'spread': '491.1526', 'groupId': 'OG003'}, {'value': '1210.967', 'spread': '874.2858', 'groupId': 'OG004'}, {'value': '1250.370', 'spread': '866.1860', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '180.340', 'spread': '82.9960', 'groupId': 'OG000'}, {'value': '289.316', 'spread': '271.1318', 'groupId': 'OG001'}, {'value': '171.673', 'spread': '98.3404', 'groupId': 'OG002'}, {'value': '121.682', 'spread': '62.5967', 'groupId': 'OG003'}, {'value': '151.990', 'spread': '82.8360', 'groupId': 'OG004'}, {'value': '118.215', 'spread': '42.3788', 'groupId': 'OG005'}]}]}, {'title': 'Plateau: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '112.503', 'spread': '10.1733', 'groupId': 'OG004'}, {'value': '716.199', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2903.100', 'spread': '1102.0127', 'groupId': 'OG000'}, {'value': '2812.484', 'spread': '1305.9088', 'groupId': 'OG001'}, {'value': '4477.582', 'spread': '3470.4282', 'groupId': 'OG002'}, {'value': '1776.276', 'spread': '923.9753', 'groupId': 'OG003'}, {'value': '2355.099', 'spread': '1345.4616', 'groupId': 'OG004'}, {'value': '2116.996', 'spread': '2015.7199', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '322.876', 'spread': '297.9631', 'groupId': 'OG000'}, {'value': '379.301', 'spread': '371.3835', 'groupId': 'OG001'}, {'value': '265.586', 'spread': '132.0434', 'groupId': 'OG002'}, {'value': '186.942', 'spread': '65.4013', 'groupId': 'OG003'}, {'value': '272.260', 'spread': '139.1806', 'groupId': 'OG004'}, {'value': '173.090', 'spread': '51.8058', 'groupId': 'OG005'}]}]}, {'title': 'Overall: Injection 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '155.577', 'spread': '50.7422', 'groupId': 'OG004'}, {'value': '832.384', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'The swing of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.\n\nCmax=maximum plasma concentration Cmin=minimum plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'percentage of Cmin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Sublingual Period (0-24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '1.017', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.000', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '23.58'}, {'value': '2.000', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '12.00'}, {'value': '2.000', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '23.67'}, {'value': '2.000', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'Initial Burst: Injection 1 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '48.00'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '48.00'}, {'value': '4.000', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '30.00'}, {'value': '12.000', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '30.00'}, {'value': '6.000', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '30.00'}, {'value': '4.000', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '36.00'}]}]}, {'title': 'Initial Burst: Injection 4 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '48.07'}, {'value': '48.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '48.10'}, {'value': '39.000', 'groupId': 'OG003', 'lowerLimit': '8.00', 'upperLimit': '48.03'}, {'value': '24.000', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '48.00'}, {'value': '12.000', 'groupId': 'OG005', 'lowerLimit': '6.00', 'upperLimit': '48.00'}]}]}, {'title': 'Initial Burst: Injection 6 (0-48 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '48.00'}]}]}, {'title': 'Plateau: Injection 1 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG001', 'lowerLimit': '48.00', 'upperLimit': '457.15'}, {'value': '48.000', 'groupId': 'OG002', 'lowerLimit': '48.00', 'upperLimit': '48.10'}, {'value': '48.000', 'groupId': 'OG003', 'lowerLimit': '48.00', 'upperLimit': '48.07'}, {'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '48.07'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '48.00'}]}]}, {'title': 'Plateau: Injection 4 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '408.52'}, {'value': '96.883', 'groupId': 'OG001', 'lowerLimit': '48.00', 'upperLimit': '604.77'}, {'value': '48.100', 'groupId': 'OG002', 'lowerLimit': '48.00', 'upperLimit': '456.80'}, {'value': '182.808', 'groupId': 'OG003', 'lowerLimit': '48.00', 'upperLimit': '629.07'}, {'value': '167.017', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '459.00'}, {'value': '303.133', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '436.75'}]}]}, {'title': 'Plateau: Injection 6 (2-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '48.00'}]}]}, {'title': 'Overall: Injection 1 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '48.00'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '457.15'}, {'value': '2.525', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '30.00'}, {'value': '6.000', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '30.00'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '30.00'}, {'value': '4.000', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '36.00'}]}]}, {'title': 'Overall: Injection 4 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '408.52'}, {'value': '48.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '604.77'}, {'value': '48.000', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '456.80'}, {'value': '182.808', 'groupId': 'OG003', 'lowerLimit': '8.00', 'upperLimit': '629.07'}, {'value': '30.067', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '459.00'}, {'value': '12.000', 'groupId': 'OG005', 'lowerLimit': '6.00', 'upperLimit': '48.00'}]}]}, {'title': 'Overall: Injection 6 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG004', 'lowerLimit': '48.00', 'upperLimit': '48.00'}, {'value': '48.000', 'groupId': 'OG005', 'lowerLimit': '48.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Results are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population was defined as any subject in Groups 1 - 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.071', 'spread': '0.4044', 'groupId': 'OG000'}, {'value': '1.924', 'spread': '1.9274', 'groupId': 'OG001'}, {'value': '1.147', 'spread': '0.5899', 'groupId': 'OG002'}, {'value': '1.709', 'spread': '0.4088', 'groupId': 'OG003'}, {'value': '1.711', 'spread': '0.5931', 'groupId': 'OG004'}, {'value': '1.247', 'spread': '0.6737', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants with data at both timepoints'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.300', 'spread': '0.1294', 'groupId': 'OG000'}, {'value': '0.697', 'spread': '0.9077', 'groupId': 'OG001'}, {'value': '0.272', 'spread': '0.1131', 'groupId': 'OG002'}, {'value': '0.548', 'spread': '0.2978', 'groupId': 'OG003'}, {'value': '0.445', 'spread': '0.2231', 'groupId': 'OG004'}, {'value': '0.730', 'spread': '0.5830', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants with data at both timepoints'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Overall: Injection 4 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '499.733', 'spread': '391.9606', 'groupId': 'OG000'}, {'value': '1583.219', 'spread': '1471.7341', 'groupId': 'OG001'}, {'value': '639.892', 'spread': '135.9113', 'groupId': 'OG002'}, {'value': '1472.769', 'groupId': 'OG004'}]}]}, {'title': 'Overall: Injection 6 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '737.097', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 85-113, 141-197', 'description': 'Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 and 6 (last injection) in subjects not participating in PET imaging sub-study only as:\n\n(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants whose data met requirements.'}, {'type': 'PRIMARY', 'title': 'Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Overall: Injection 4 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '405.325', 'spread': '47.4883', 'groupId': 'OG000'}, {'value': '241.914', 'spread': '114.8553', 'groupId': 'OG001'}, {'value': '334.080', 'spread': '48.0676', 'groupId': 'OG002'}, {'value': '310.879', 'groupId': 'OG004'}]}]}, {'title': 'Overall: Injection 6 (0-28 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '158.840', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 85-113, 141-197', 'description': 'The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population of participants whose data met requirements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Baseline (observed values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '3.22', 'groupId': 'OG001'}, {'value': '20.4', 'spread': '4.42', 'groupId': 'OG002'}, {'value': '16.2', 'spread': '2.91', 'groupId': 'OG003'}, {'value': '17.9', 'spread': '3.65', 'groupId': 'OG004'}, {'value': '16.7', 'spread': '2.33', 'groupId': 'OG005'}]}]}, {'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-16.53', 'spread': '3.335', 'groupId': 'OG000'}, {'value': '-16.33', 'spread': '4.152', 'groupId': 'OG001'}, {'value': '-19.33', 'spread': '4.670', 'groupId': 'OG002'}, {'value': '-15.50', 'spread': '2.324', 'groupId': 'OG003'}, {'value': '-16.80', 'spread': '3.986', 'groupId': 'OG004'}, {'value': '-15.93', 'spread': '2.056', 'groupId': 'OG005'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '3.155', 'groupId': 'OG000'}, {'value': '-16.73', 'spread': '3.788', 'groupId': 'OG001'}, {'value': '-19.27', 'spread': '4.891', 'groupId': 'OG002'}, {'value': '-15.60', 'spread': '2.720', 'groupId': 'OG003'}, {'value': '-16.87', 'spread': '3.563', 'groupId': 'OG004'}, {'value': '-16.36', 'spread': '2.341', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-16.80', 'spread': '2.908', 'groupId': 'OG000'}, {'value': '-16.79', 'spread': '3.262', 'groupId': 'OG001'}, {'value': '-19.92', 'spread': '4.663', 'groupId': 'OG002'}, {'value': '-15.77', 'spread': '3.059', 'groupId': 'OG003'}, {'value': '-16.71', 'spread': '3.989', 'groupId': 'OG004'}, {'value': '-16.91', 'spread': '2.548', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-17.75', 'spread': '3.108', 'groupId': 'OG000'}, {'value': '-16.62', 'spread': '3.776', 'groupId': 'OG001'}, {'value': '-18.91', 'spread': '4.253', 'groupId': 'OG002'}, {'value': '-16.08', 'spread': '2.937', 'groupId': 'OG003'}, {'value': '-17.62', 'spread': '3.453', 'groupId': 'OG004'}, {'value': '-17.00', 'spread': '2.449', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-18.09', 'spread': '3.015', 'groupId': 'OG000'}, {'value': '-17.08', 'spread': '3.895', 'groupId': 'OG001'}, {'value': '-19.55', 'spread': '4.059', 'groupId': 'OG002'}, {'value': '-16.10', 'spread': '2.998', 'groupId': 'OG003'}, {'value': '-18.00', 'spread': '3.873', 'groupId': 'OG004'}, {'value': '-16.00', 'spread': '2.828', 'groupId': 'OG005'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-19.67', 'spread': '4.041', 'groupId': 'OG004'}, {'value': '-18.00', 'spread': '4.243', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141', 'description': 'COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. Each participant was to be assessed by the same qualified and trained individuals throughout the course of the study as much as possible.\n\nBaseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of withdrawal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) population included subjects in Cohorts 1 - 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Baseline (observed values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '11.14', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '14.65', 'groupId': 'OG001'}, {'value': '45.1', 'spread': '11.89', 'groupId': 'OG002'}, {'value': '42.7', 'spread': '13.80', 'groupId': 'OG003'}, {'value': '42.1', 'spread': '15.41', 'groupId': 'OG004'}, {'value': '43.9', 'spread': '16.20', 'groupId': 'OG005'}]}]}, {'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-38.07', 'spread': '11.145', 'groupId': 'OG000'}, {'value': '-45.20', 'spread': '16.794', 'groupId': 'OG001'}, {'value': '-43.40', 'spread': '12.385', 'groupId': 'OG002'}, {'value': '-40.67', 'spread': '13.563', 'groupId': 'OG003'}, {'value': '-39.47', 'spread': '16.048', 'groupId': 'OG004'}, {'value': '-42.71', 'spread': '17.117', 'groupId': 'OG005'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-38.73', 'spread': '11.285', 'groupId': 'OG000'}, {'value': '-45.60', 'spread': '16.106', 'groupId': 'OG001'}, {'value': '-43.47', 'spread': '12.489', 'groupId': 'OG002'}, {'value': '-40.80', 'spread': '13.624', 'groupId': 'OG003'}, {'value': '-39.67', 'spread': '15.041', 'groupId': 'OG004'}, {'value': '-42.57', 'spread': '16.603', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-38.20', 'spread': '12.616', 'groupId': 'OG000'}, {'value': '-45.64', 'spread': '16.832', 'groupId': 'OG001'}, {'value': '-44.15', 'spread': '11.689', 'groupId': 'OG002'}, {'value': '-40.62', 'spread': '13.997', 'groupId': 'OG003'}, {'value': '-39.64', 'spread': '15.979', 'groupId': 'OG004'}, {'value': '-46.00', 'spread': '15.205', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-39.50', 'spread': '11.844', 'groupId': 'OG000'}, {'value': '-46.07', 'spread': '16.717', 'groupId': 'OG001'}, {'value': '-43.09', 'spread': '11.631', 'groupId': 'OG002'}, {'value': '-39.50', 'spread': '13.945', 'groupId': 'OG003'}, {'value': '-38.85', 'spread': '15.486', 'groupId': 'OG004'}, {'value': '-49.20', 'spread': '12.770', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-38.36', 'spread': '11.595', 'groupId': 'OG000'}, {'value': '-45.58', 'spread': '16.654', 'groupId': 'OG001'}, {'value': '-43.82', 'spread': '11.763', 'groupId': 'OG002'}, {'value': '-41.60', 'spread': '14.819', 'groupId': 'OG003'}, {'value': '-41.27', 'spread': '15.691', 'groupId': 'OG004'}, {'value': '-51.71', 'spread': '13.793', 'groupId': 'OG005'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-45.67', 'spread': '5.132', 'groupId': 'OG004'}, {'value': '-59.50', 'spread': '6.364', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141', 'description': 'The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms).\n\nBaseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of withdrawal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) population included subjects in Cohorts 1 - 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Baseline (observed values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '85.6', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '89.7', 'spread': '10.13', 'groupId': 'OG001'}, {'value': '87.2', 'spread': '10.41', 'groupId': 'OG002'}, {'value': '86.0', 'spread': '7.67', 'groupId': 'OG003'}, {'value': '85.1', 'spread': '12.64', 'groupId': 'OG004'}, {'value': '87.4', 'spread': '11.56', 'groupId': 'OG005'}]}]}, {'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-84.00', 'spread': '10.569', 'groupId': 'OG000'}, {'value': '-86.93', 'spread': '14.255', 'groupId': 'OG001'}, {'value': '-84.53', 'spread': '11.141', 'groupId': 'OG002'}, {'value': '-83.33', 'spread': '8.449', 'groupId': 'OG003'}, {'value': '-82.07', 'spread': '12.975', 'groupId': 'OG004'}, {'value': '-85.21', 'spread': '11.088', 'groupId': 'OG005'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-84.47', 'spread': '10.569', 'groupId': 'OG000'}, {'value': '-88.20', 'spread': '11.027', 'groupId': 'OG001'}, {'value': '-84.40', 'spread': '11.451', 'groupId': 'OG002'}, {'value': '-83.73', 'spread': '8.293', 'groupId': 'OG003'}, {'value': '-83.00', 'spread': '12.689', 'groupId': 'OG004'}, {'value': '-85.36', 'spread': '11.263', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-81.73', 'spread': '15.975', 'groupId': 'OG000'}, {'value': '-85.00', 'spread': '12.247', 'groupId': 'OG001'}, {'value': '-85.31', 'spread': '11.272', 'groupId': 'OG002'}, {'value': '-83.46', 'spread': '8.771', 'groupId': 'OG003'}, {'value': '-82.36', 'spread': '14.836', 'groupId': 'OG004'}, {'value': '-88.45', 'spread': '10.377', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-84.42', 'spread': '11.437', 'groupId': 'OG000'}, {'value': '-86.64', 'spread': '11.167', 'groupId': 'OG001'}, {'value': '-86.36', 'spread': '11.792', 'groupId': 'OG002'}, {'value': '-82.08', 'spread': '9.229', 'groupId': 'OG003'}, {'value': '-83.85', 'spread': '13.459', 'groupId': 'OG004'}, {'value': '-88.10', 'spread': '10.482', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-84.91', 'spread': '12.136', 'groupId': 'OG000'}, {'value': '-84.92', 'spread': '13.507', 'groupId': 'OG001'}, {'value': '-86.55', 'spread': '11.725', 'groupId': 'OG002'}, {'value': '-85.70', 'spread': '6.848', 'groupId': 'OG003'}, {'value': '-89.27', 'spread': '7.157', 'groupId': 'OG004'}, {'value': '-87.14', 'spread': '11.668', 'groupId': 'OG005'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-85.33', 'spread': '1.528', 'groupId': 'OG004'}, {'value': '-85.00', 'spread': '4.243', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141', 'description': 'The Total Score was the sum of 10 questions regarding cravings each ranging from 0 (no craving) - 10 (extreme craving) for a total range from 0 (no cravings") to 100 ("most intense craving I have ever had").\n\nBaseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of craving symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) population included subjects in Cohorts 1 - 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Baseline (observed values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '0.51', 'groupId': 'OG003'}, {'value': '4.7', 'spread': '0.72', 'groupId': 'OG004'}, {'value': '4.6', 'spread': '0.51', 'groupId': 'OG005'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.352', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG005'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.095', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.527', 'groupId': 'OG001'}, {'value': '-1.25', 'spread': '0.965', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '1.056', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.038', 'groupId': 'OG001'}, {'value': '-1.23', 'spread': '0.927', 'groupId': 'OG002'}, {'value': '-1.38', 'spread': '0.961', 'groupId': 'OG003'}, {'value': '-1.64', 'spread': '0.929', 'groupId': 'OG004'}, {'value': '-1.91', 'spread': '1.044', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '1.055', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '1.204', 'groupId': 'OG001'}, {'value': '-1.91', 'spread': '1.221', 'groupId': 'OG002'}, {'value': '-1.83', 'spread': '1.115', 'groupId': 'OG003'}, {'value': '-2.00', 'spread': '1.000', 'groupId': 'OG004'}, {'value': '-2.50', 'spread': '1.269', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.82', 'spread': '0.751', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '1.115', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '0.874', 'groupId': 'OG002'}, {'value': '-2.30', 'spread': '1.160', 'groupId': 'OG003'}, {'value': '-2.64', 'spread': '1.120', 'groupId': 'OG004'}, {'value': '-2.86', 'spread': '1.345', 'groupId': 'OG005'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '1.000', 'groupId': 'OG004'}, {'value': '-2.00', 'spread': '2.828', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141', 'description': 'The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).\n\nBaseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of the severity of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) population included subjects in Cohorts 1 - 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter. One participant from Group 2 did not have a baseline evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Baseline (observed values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '4.0', 'spread': '0.00', 'groupId': 'OG005'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.095', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.905', 'groupId': 'OG001'}, {'value': '-1.42', 'spread': '1.084', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '0.976', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '1.072', 'groupId': 'OG001'}, {'value': '-1.77', 'spread': '1.092', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '0.947', 'groupId': 'OG003'}, {'value': '02.07', 'spread': '0.616', 'groupId': 'OG004'}, {'value': '-2.27', 'spread': '1.191', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.08', 'spread': '0.793', 'groupId': 'OG000'}, {'value': '-1.79', 'spread': '0.975', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '0.809', 'groupId': 'OG002'}, {'value': '-2.17', 'spread': '0.937', 'groupId': 'OG003'}, {'value': '-2.15', 'spread': '0.801', 'groupId': 'OG004'}, {'value': '-2.40', 'spread': '0.966', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.603', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '0.953', 'groupId': 'OG001'}, {'value': '-2.73', 'spread': '0.467', 'groupId': 'OG002'}, {'value': '-2.60', 'spread': '0.699', 'groupId': 'OG003'}, {'value': '-2.73', 'spread': '0.647', 'groupId': 'OG004'}, {'value': '-2.57', 'spread': '0.787', 'groupId': 'OG005'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.67', 'spread': '0.577', 'groupId': 'OG004'}, {'value': '-2.50', 'spread': '0.707', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Days 7, 29, 57, 85, 141', 'description': 'The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).\n\nBaseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.\n\nNegative change from baseline values indicate an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) population included subjects in Cohorts 1 - 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter. One participant from Group 6 did not have a baseline evaluation.'}, {'type': 'SECONDARY', 'title': 'Columbia Suicide Severity Rating Scale (C-SSRS): Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'title': 'Screening (summary of lifetime)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '1.41', 'groupId': 'OG003'}, {'value': '1.0', 'groupId': 'OG004'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG005'}]}]}, {'title': 'Screening (last 6 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG005'}]}]}, {'title': 'Day 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG004'}, {'value': '1.0', 'groupId': 'OG005'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'End of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)', 'description': 'The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD population'}, {'type': 'SECONDARY', 'title': 'Percentage of Urine Drug Screen Samples Negative for Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'OG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'OG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'OG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'OG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '32.89', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '35.43', 'groupId': 'OG001'}, {'value': '54.6', 'spread': '23.98', 'groupId': 'OG002'}, {'value': '49.9', 'spread': '25.53', 'groupId': 'OG003'}, {'value': '41.6', 'spread': '27.68', 'groupId': 'OG004'}, {'value': '64.9', 'spread': '23.56', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to End of Study (up to day 365)', 'description': 'Urine samples were screened for the following drugs:\n\n* opiates\n* cocaine\n* amphetamines\n* methadone\n* cannabinoids\n* barbiturates\n* buprenorphine. Buprenorphine was only included in the urine drug screen at screening and Day -14 to determine if the subject had used any buprenorphine-containing products prior to the start of SUBUTEX SL tablet dosing.\n* benzodiazepines\n* methamphetamine\n* phencyclidine\n\nUrine drug screens were run every day when the participant was an inpatient; every 2-3 days when the participant was an outpatient. Drug screens were run less often for those participants in the PET substudy.', 'unitOfMeasure': 'percentage of total urine drug samples', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SUBUTEX', 'description': 'Participants who entered the Induction/Stabalization period, were treated with SUBUTEX SL. Those who did not complete this period, did not continue into the Treatment period.'}, {'id': 'FG001', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'FG002', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'FG003', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'FG004', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'FG005', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'FG006', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}], 'periods': [{'title': 'Induction/Stabilization (Days -14 to -1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Completed to Day 113 (4 injections)', 'groupId': 'FG001', 'numSubjects': '10'}, {'comment': 'Completed to Day 113 (4 injections)', 'groupId': 'FG002', 'numSubjects': '10'}, {'comment': 'Completed to Day 113 (4 injections)', 'groupId': 'FG003', 'numSubjects': '9'}, {'comment': 'Completed to Day 113 (4 injections)', 'groupId': 'FG004', 'numSubjects': '7'}, {'comment': 'Completed to Day 113 (4 injections)', 'groupId': 'FG005', 'numSubjects': '9'}, {'comment': 'Completed to Day 113 (4 injections)', 'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'PET Imaging Sub-study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Completion defined as a total of 12 injections plus all PET images', 'groupId': 'FG005', 'numSubjects': '1'}, {'comment': 'Completion defined as a total of 6 injections plus all PET images', 'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Scheduling issues with imaging facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 395 subjects provided informed consent to participate in the main study and underwent screening procedures. Of these 395 subjects, 124 received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.'}, {'id': 'BG001', 'title': 'Group 2 (12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals'}, {'id': 'BG002', 'title': 'Group 3 (24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'BG003', 'title': 'Group 4 (8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.'}, {'id': 'BG004', 'title': 'Group 5 (14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who reach Day 113 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'BG005', 'title': 'Group 6 (8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, up to six subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.\n\nParticipants who reach Day 168 (and have received all 6 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 300 mg SC injections at 28 day intervals for an additional 6 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '36.5', 'spread': '11.36', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '11.14', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '11.21', 'groupId': 'BG002'}, {'value': '36.1', 'spread': '14.87', 'groupId': 'BG003'}, {'value': '36.2', 'spread': '12.85', 'groupId': 'BG004'}, {'value': '32.9', 'spread': '11.00', 'groupId': 'BG005'}, {'value': '33.8', 'spread': '12.10', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '71.12', 'spread': '12.929', 'groupId': 'BG000'}, {'value': '73.71', 'spread': '10.411', 'groupId': 'BG001'}, {'value': '68.08', 'spread': '9.900', 'groupId': 'BG002'}, {'value': '74.43', 'spread': '15.995', 'groupId': 'BG003'}, {'value': '73.16', 'spread': '12.753', 'groupId': 'BG004'}, {'value': '74.64', 'spread': '16.825', 'groupId': 'BG005'}, {'value': '72.50', 'spread': '13.159', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '173.41', 'spread': '8.514', 'groupId': 'BG000'}, {'value': '172.87', 'spread': '8.532', 'groupId': 'BG001'}, {'value': '170.50', 'spread': '11.738', 'groupId': 'BG002'}, {'value': '171.17', 'spread': '8.701', 'groupId': 'BG003'}, {'value': '168.71', 'spread': '10.963', 'groupId': 'BG004'}, {'value': '170.64', 'spread': '11.469', 'groupId': 'BG005'}, {'value': '171.22', 'spread': '9.906', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '23.55', 'spread': '3.084', 'groupId': 'BG000'}, {'value': '24.67', 'spread': '3.239', 'groupId': 'BG001'}, {'value': '23.39', 'spread': '2.298', 'groupId': 'BG002'}, {'value': '25.26', 'spread': '4.295', 'groupId': 'BG003'}, {'value': '25.67', 'spread': '3.635', 'groupId': 'BG004'}, {'value': '25.36', 'spread': '3.355', 'groupId': 'BG005'}, {'value': '24.64', 'spread': '3.394', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Other Opioid Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '6.75', 'spread': '5.545', 'groupId': 'BG000'}, {'value': '6.18', 'spread': '4.191', 'groupId': 'BG001'}, {'value': '4.17', 'spread': '2.887', 'groupId': 'BG002'}, {'value': '5.27', 'spread': '3.927', 'groupId': 'BG003'}, {'value': '8.36', 'spread': '9.770', 'groupId': 'BG004'}, {'value': '6.30', 'spread': '8.693', 'groupId': 'BG005'}, {'value': '6.15', 'spread': '6.165', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing participants reported no use'}, {'title': 'Heroin Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '11.25', 'spread': '10.463', 'groupId': 'BG000'}, {'value': '9.78', 'spread': '11.454', 'groupId': 'BG001'}, {'value': '5.00', 'spread': '5.604', 'groupId': 'BG002'}, {'value': '11.64', 'spread': '12.549', 'groupId': 'BG003'}, {'value': '10.70', 'spread': '7.987', 'groupId': 'BG004'}, {'value': '8.56', 'spread': '12.471', 'groupId': 'BG005'}, {'value': '9.62', 'spread': '10.292', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing participants reported no use'}, {'title': 'Smoking History (Nicotine Use)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '81', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '15.14', 'spread': '10.596', 'groupId': 'BG000'}, {'value': '10.64', 'spread': '5.387', 'groupId': 'BG001'}, {'value': '9.57', 'spread': '8.225', 'groupId': 'BG002'}, {'value': '19.83', 'spread': '14.282', 'groupId': 'BG003'}, {'value': '20.07', 'spread': '11.526', 'groupId': 'BG004'}, {'value': '17.31', 'spread': '13.054', 'groupId': 'BG005'}, {'value': '15.30', 'spread': '11.243', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing participants reported no use'}], 'populationDescription': 'Safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2015-05-15', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2012-11-28', 'dispFirstSubmitQcDate': '2015-05-15', 'resultsFirstSubmitDate': '2017-12-30', 'studyFirstSubmitQcDate': '2012-11-28', 'dispFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-30', 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Days -14 to -1 (Subutex treatment), Days 1-316 (RBP-6000 treatment)', 'description': 'TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following outcomes: death; lifethreatening AE; hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacit'}, {'measure': 'Buprenorphine PK: % Fluctuation', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': '% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg\\*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Average Plasma Concentration (Cavg)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Maximum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Minimum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Swing of Plasma Concentrations', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'The swing of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.\n\nCmax=maximum plasma concentration Cmin=minimum plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Results are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Buprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).'}, {'measure': 'Buprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.'}, {'measure': 'Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6', 'timeFrame': 'Days 85-113, 141-169', 'description': 'Apparent clearance at steady-state (CLss/F) = Dose / AUCtau (tau was 28 days).'}, {'measure': 'Buprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 (AUC0-∞)', 'timeFrame': 'Days 85-113', 'description': 'Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 (last injection) in subjects not participating in PET imaging sub-study only as:\n\n(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule.'}, {'measure': 'Buprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4', 'timeFrame': 'Days 85-113', 'description': 'The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.'}, {'measure': 'Norbuprenorphine PK: % Fluctuation', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': '% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg\\*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Average Plasma Concentration (Cavg)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Maximum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Minimum observed plasma concentration, determined directly from individual concentration time data.\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Swing of Plasma Concentrations', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'The swing of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.\n\nCmax=maximum plasma concentration Cmin=minimum plasma concentration\n\nResults are reported across three timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)', 'timeFrame': 'Day -1, Days 1-29, 85-113, 141-197', 'description': 'Results are reported across four timeframes:\n\n* Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.\n* Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48\n* Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672\n* Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672\n\nThe PK sampling schedule was\n\n* hour 0 (predose) on days -7 to -1,\n* hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4\n* hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6'}, {'measure': 'Norbuprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).'}, {'measure': 'Norbuprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))', 'timeFrame': 'Days 1-28, 85-113', 'description': 'Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.'}, {'measure': 'Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞)', 'timeFrame': 'Days 85-113, 141-197', 'description': 'Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 and 6 (last injection) in subjects not participating in PET imaging sub-study only as:\n\n(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule.'}, {'measure': 'Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4', 'timeFrame': 'Days 85-113, 141-197', 'description': 'The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6', 'timeFrame': 'Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141', 'description': 'COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. Each participant was to be assessed by the same qualified and trained individuals throughout the course of the study as much as possible.\n\nBaseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of withdrawal symptoms.'}, {'measure': 'Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6', 'timeFrame': 'Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141', 'description': 'The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms).\n\nBaseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of withdrawal symptoms.'}, {'measure': 'Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6', 'timeFrame': 'Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141', 'description': 'The Total Score was the sum of 10 questions regarding cravings each ranging from 0 (no craving) - 10 (extreme craving) for a total range from 0 (no cravings") to 100 ("most intense craving I have ever had").\n\nBaseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of craving symptoms.'}, {'measure': 'Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141', 'timeFrame': 'Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141', 'description': 'The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).\n\nBaseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.\n\nNegative change from baseline values indicate a lessening of the severity of symptoms.'}, {'measure': 'Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141', 'timeFrame': 'Baseline (Day 1), Days 7, 29, 57, 85, 141', 'description': 'The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).\n\nBaseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.\n\nNegative change from baseline values indicate an improvement.'}, {'measure': 'Columbia Suicide Severity Rating Scale (C-SSRS): Severity', 'timeFrame': 'Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)', 'description': 'The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent.'}, {'measure': 'Percentage of Urine Drug Screen Samples Negative for Opioids', 'timeFrame': 'Day 1 to End of Study (up to day 365)', 'description': 'Urine samples were screened for the following drugs:\n\n* opiates\n* cocaine\n* amphetamines\n* methadone\n* cannabinoids\n* barbiturates\n* buprenorphine. Buprenorphine was only included in the urine drug screen at screening and Day -14 to determine if the subject had used any buprenorphine-containing products prior to the start of SUBUTEX SL tablet dosing.\n* benzodiazepines\n* methamphetamine\n* phencyclidine\n\nUrine drug screens were run every day when the participant was an inpatient; every 2-3 days when the participant was an outpatient. Drug screens were run less often for those participants in the PET substudy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid Dependence, Buprenorphine, Depot, SUBUTEX, RBP-6000'], 'conditions': ['Opioid Related Disorder']}, 'descriptionModule': {'briefSummary': 'This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subutex.\n\nSubjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28 days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a 13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose levels of 8-24 mg.', 'detailedDescription': '* Open-label SUBUTEX Sublingual Tablet Induction and Stabilisation Period After completing the screening period, subjects entered an open-label SUBUTEX SL tablet induction and stabilisation period to achieve stable daily doses of 8 mg, 12 mg, 14 mg, 24 mg or 8 - 24 mg (variable) during a 13 day inpatient (Day -14 to Day -1) period.\n* Open-label Treatment Phase On Day 1, eligible subjects discontinued use of SUBUTEX SL tablet and received a subcutaneous (SC) injection of RBP-6000. The dose of RBP-6000 received and the cohort to which a subject was assigned depended upon the SUBUTEX SL tablet dose on Day -1.\n\n * Injection 1 (Day 1): 3 days inpatient post-dose (Day 1 to Day 3) and outpatient visits (Day 4 to Day 28); serial pharmacokinetic (PK) samples\n * Injection 2 (Day 29): 60-hour inpatient pre-dose and post-dose (Day 28 to Day 31) and outpatient visits (Day 32 to Day 56); sparse PK samples\n * Injection 3 (Day 57): 60-hour inpatient pre-dose and post-dose (Day 56 to Day 59) and outpatient visits (Day 60 to Day 84); sparse PK samples\n * Injection 4 (Day 85): 60-hour inpatient pre-dose and post-dose (Day 84 to Day 87) and outpatient visits (Day 88 to Day 113 \\[or Day 112 for Cohort 6\\]); serial PK samples\n * Cohort 6 ONLY: Injection 5 (Day 113): 60-hour inpatient pre-dose and post-dose (Day 112 to Day 115) and outpatient visits (Day 116 to Day 140); serial PK samples\n * Cohort 6 ONLY: Injection 6 (Day 141): 60-hour inpatient pre- and post-dose (Day 140 to Day 143) and outpatient visits (Day 144 to Day 169); serial PK samples\n * Safety Follow-up: weekly visits up to 60 days post-Injection 4 (PK Day 114 to Day 141) for subjects in Cohorts 1-5 who did not take part in the positron emission tomography (PET) imaging sub-study and up to 60 days post-Injection 6 (PK Day 169 to Day 197) for subjects in Cohort 6\n\nThe objective of the PET imaging sub-study was to evaluate the relationship between buprenorphine plasma levels and the ability of the 200 mg and 300 mg doses of RBP-6000 to reduce mu-opioid receptor availability measured with \\[11C\\]carfentanil and positron emission tomography (PET) scans. This objective was exploratory in nature and results are not reported as part of these summary results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects\n* Agree not to take any buprenorphine products other than those administered for the current study throughout participation in the study\n* Body mass index (BMI) of \\>18.0 to \\< 33.0 kg/m\n\nExclusion Criteria:\n\n* Participants with a current diagnosis requiring chronic opioid treatment\n* Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) \\>450 msec in males and QTcF \\> 470 in females at screening\n* Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent"}, 'identificationModule': {'nctId': 'NCT01738503', 'briefTitle': 'Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Indivior Inc.'}, 'officialTitle': 'Open-Label, Multicenter, Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, Efficacy Markers, and Opioid Receptor Availability of Subcutaneous Injections of Depot Buprenorphine in Treatment Seeking Opioid-Dependent Subjects', 'orgStudyIdInfo': {'id': 'RB-US-12-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(8 mg) RBP-6000: 50 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 50 mg are given at 28 day intervals.', 'interventionNames': ['Drug: RBP-6000', 'Drug: Subutex']}, {'type': 'EXPERIMENTAL', 'label': '(12 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 12 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals', 'interventionNames': ['Drug: RBP-6000', 'Drug: Subutex']}, {'type': 'EXPERIMENTAL', 'label': '(24 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who receive RBP-6000 containing 200 mg buprenorphine and reach Day 112 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.', 'interventionNames': ['Drug: RBP-6000', 'Drug: Subutex']}, {'type': 'EXPERIMENTAL', 'label': '(8 mg) RBP-6000: 100 mg', 'description': 'Participants are stabilized by day -5 on Subutex 8 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 100 mg are given at 28 day intervals.', 'interventionNames': ['Drug: RBP-6000', 'Drug: Subutex']}, {'type': 'EXPERIMENTAL', 'label': '(14 mg) RBP-6000: 200 mg', 'description': 'Participants are stabilized by day -5 on Subutex 14 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 200 mg are given at 28 day intervals.\n\nParticipants who receive RBP-6000 containing 200 mg buprenorphine and reach Day 112 (and have received all 4 planned SC injections) have the option to participate in the Positron Emission Tomography (PET) Pilot substudy. In the PET Pilot sub-study participants remain on 200 mg SC injections at 28 day intervals for an additional 6-9 intervals until they complete an magnetic resonance imaging (MRI) and a PET scan and pharmacokinetic samples at week 1 and week 4 post injection.', 'interventionNames': ['Drug: RBP-6000', 'Drug: Subutex']}, {'type': 'EXPERIMENTAL', 'label': '(8-24 mg) RBP-6000: 300 mg', 'description': 'Participants are stabilized by day -5 on a Subutex between 8-24 mg. During the study, four subcutaneous (SC) injections containing RBP-6000 300 mg are given at 28 day intervals.', 'interventionNames': ['Drug: RBP-6000', 'Drug: Subutex']}], 'interventions': [{'name': 'RBP-6000', 'type': 'DRUG', 'otherNames': ['buprenorphine'], 'description': "18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and given on alternate sides of the participant's abdomen.", 'armGroupLabels': ['(12 mg) RBP-6000: 100 mg', '(14 mg) RBP-6000: 200 mg', '(24 mg) RBP-6000: 200 mg', '(8 mg) RBP-6000: 100 mg', '(8 mg) RBP-6000: 50 mg', '(8-24 mg) RBP-6000: 300 mg']}, {'name': 'Subutex', 'type': 'DRUG', 'otherNames': ['buprenorphine'], 'description': 'Participants were inducted and stabilized over a 14-day period (study days -14 to -1) on SUBUTEX sublingual tablets. Tablets are placed under the tongue until dissolved.', 'armGroupLabels': ['(12 mg) RBP-6000: 100 mg', '(14 mg) RBP-6000: 200 mg', '(24 mg) RBP-6000: 200 mg', '(8 mg) RBP-6000: 100 mg', '(8 mg) RBP-6000: 50 mg', '(8-24 mg) RBP-6000: 300 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Bradley D Vince, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vince and Associates Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indivior Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}