Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02007434
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Experience Study of Deoxycholic Acid Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D017336', 'term': 'Loratadine'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical_trials@kythera.com', 'title': 'Clinical Trial Disclosure', 'organization': 'Kythera'}, 'certainAgreement': {'otherDetails': 'The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '84 days', 'eventGroups': [{'id': 'EG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'otherNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Application site alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Skin tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Pain Visual Analog Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-2', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.6803', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Placebo-adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '1.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'estimateComment': 'Paradigm 1 - Paradigm 2', 'groupDescription': 'Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5206', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Placebo-adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '1.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'estimateComment': 'Paradigm 1 - Paradigm 3', 'groupDescription': 'Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6060', 'groupIds': ['OG000', 'OG006'], 'paramType': 'LS Mean Placebo-adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '395', 'paramValue': '0.30', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '1.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'estimateComment': 'Paradigm 1 - Paradigm 4', 'groupDescription': 'Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7935', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LS Mean Placebo-adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '1.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'estimateComment': 'Paradigm 2 - Paradigm 3', 'groupDescription': 'Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9140', 'groupIds': ['OG002', 'OG006'], 'paramType': 'LS Mean Placebo-adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '1.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'estimateComment': 'Paradigm 2 - Paradigm 4', 'groupDescription': 'Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8754', 'groupIds': ['OG004', 'OG006'], 'paramType': 'LS Mean Placebo-adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '1.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'estimateComment': 'Paradigm 3 - Paradigm 4', 'groupDescription': 'Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 84', 'description': 'Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. 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topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 to 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable 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'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Stabbing', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Sharp', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Cramping', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Gnawing', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Hot-Burning', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Aching', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.25', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.25', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Tender', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.25', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Splitting', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Tiring-Exhausting', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Sickening', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Fearful', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Punishing-Cruel', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}, {'title': 'Present pain', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose) and Day 84', 'description': 'Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at both time points'}, {'type': 'PRIMARY', 'title': 'Swelling Grading Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'The following grading system was used for the assessment of swelling:\n\n* Swelling/edema absent (0)\n* Minimal swelling/edema contained within treatment area (1)\n* Modest swelling/edema contained within treatment area (2)\n* Substantial swelling/edema contained within treatment area (3)\n* Swelling/edema of the neck and face beyond the treatment area (4)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data'}, {'type': 'PRIMARY', 'title': 'Bruising Grading Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'The following grading system was used for the assessment of bruising:\n\n* Bruising absent (0)\n* Bruising associated with 1 to 3 needle insertion points (1)\n* Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)\n* Bruising covering the entire treatment area but contained within the treatment area (3)\n* Bruising of the neck and face beyond the treatment area (4)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data'}, {'type': 'PRIMARY', 'title': 'Induration Grading Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '0.1', 'spread': '0.32', 'groupId': 'OG006'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'The following grading system was used for the assessment of induration:\n\n* Induration absent to minimal (0)\n* Induration associated with at least approximately 30% of the treatment area (1)\n* Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)\n* Induration covering the entire treatment area but contained within the treatment area (3)\n* Induration of the neck and face beyond the treatment area (4)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.82', 'groupId': 'OG005'}, {'value': '-0.4', 'spread': '0.50', 'groupId': 'OG006'}, {'value': '-0.3', 'spread': '0.50', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 84', 'description': "The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.29', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-0.8', 'spread': '0.50', 'groupId': 'OG005'}, {'value': '-0.7', 'spread': '0.57', 'groupId': 'OG006'}, {'value': '-0.5', 'spread': '0.58', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 84', 'description': 'The PR-SMFRS is based on the participant\'s response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at both time points'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Self Rating Scale (SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '3.51', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.71', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '1.95', 'groupId': 'OG004'}, {'value': '2.3', 'spread': '1.50', 'groupId': 'OG005'}, {'value': '2.4', 'spread': '1.38', 'groupId': 'OG006'}, {'value': '2.0', 'spread': '1.41', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 84', 'description': "The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at both time points'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Submental Skin Laxity Grades (SMSLG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.58', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.45', 'groupId': 'OG004'}, {'value': '0.5', 'spread': '0.58', 'groupId': 'OG005'}, {'value': '0.3', 'spread': '0.67', 'groupId': 'OG006'}, {'value': '0.3', 'spread': '0.50', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 84', 'description': 'Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at both time points'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Submental Fat Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '2.34', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '2.75', 'groupId': 'OG003'}, {'value': '-0.9', 'spread': '3.77', 'groupId': 'OG004'}, {'value': '-2.3', 'spread': '2.22', 'groupId': 'OG005'}, {'value': '-1.5', 'spread': '3.33', 'groupId': 'OG006'}, {'value': '-2.8', 'spread': '2.22', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 84', 'description': 'Submental thickness was measured using caliper devices.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at both time points'}, {'type': 'SECONDARY', 'title': 'Patient Experience Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'OG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'OG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'OG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'classes': [{'title': 'Recommend to a Friend', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}]}]}, {'title': 'Receive Additional Treatments', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}, {'value': '78', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}]}]}, {'title': 'Normal Activity Affected', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 84', 'description': 'Participants were asked to complete 3 patient experience questions, each answered as Yes or No:\n\nGiven your experience in this study:\n\n1. Would you recommend this procedure to a friend?\n2. Would you agree to receive additional treatments?\n3. Has the treatment you received in this study affected your normal activities?\n\nThe percentage of participants answering Yes on each question is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set with available data at each time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale \\[CR-SMFRS\\] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'FG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'FG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'FG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'FG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'FG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'FG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'FG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was performed at one investigational center in the United States (US).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '83', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'BG001', 'title': 'Paradigm 1 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.'}, {'id': 'BG002', 'title': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.'}, {'id': 'BG003', 'title': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'BG004', 'title': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'BG005', 'title': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'BG006', 'title': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'BG007', 'title': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '11.08', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '14.05', 'groupId': 'BG001'}, {'value': '42.4', 'spread': '13.08', 'groupId': 'BG002'}, {'value': '43.8', 'spread': '11.67', 'groupId': 'BG003'}, {'value': '41.3', 'spread': '11.48', 'groupId': 'BG004'}, {'value': '44.8', 'spread': '14.84', 'groupId': 'BG005'}, {'value': '42.3', 'spread': '13.08', 'groupId': 'BG006'}, {'value': '48.0', 'spread': '8.64', 'groupId': 'BG007'}, {'value': '43.5', 'spread': '12.07', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '51', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '32', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '66', 'groupId': 'BG008'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}]}, {'title': 'American Indian/Alaskan Native', 'categories': [{'measurements': [{'value': '1', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '191.01', 'spread': '40.086', 'groupId': 'BG000'}, {'value': '221.00', 'spread': '34.492', 'groupId': 'BG001'}, {'value': '205.61', 'spread': '38.716', 'groupId': 'BG002'}, {'value': '223.90', 'spread': '27.534', 'groupId': 'BG003'}, {'value': '205.74', 'spread': '32.847', 'groupId': 'BG004'}, {'value': '217.90', 'spread': '11.485', 'groupId': 'BG005'}, {'value': '200.30', 'spread': '36.592', 'groupId': 'BG006'}, {'value': '185.05', 'spread': '68.356', 'groupId': 'BG007'}, {'value': '202.53', 'spread': '37.514', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.959', 'spread': '4.2723', 'groupId': 'BG000'}, {'value': '28.867', 'spread': '4.9923', 'groupId': 'BG001'}, {'value': '33.206', 'spread': '4.9806', 'groupId': 'BG002'}, {'value': '33.350', 'spread': '3.1586', 'groupId': 'BG003'}, {'value': '32.763', 'spread': '3.7764', 'groupId': 'BG004'}, {'value': '36.850', 'spread': '2.3587', 'groupId': 'BG005'}, {'value': '31.706', 'spread': '3.3457', 'groupId': 'BG006'}, {'value': '31.250', 'spread': '7.7229', 'groupId': 'BG007'}, {'value': '32.266', 'spread': '4.3474', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'I-III', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '36', 'groupId': 'BG008'}]}]}, {'title': 'IV-VI', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '47', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:\n\n* Type I: Pale white skin, blue/hazel eyes, blond/red hair; Always burns, does not tan.\n* Type II: Fair skin, blue eyes; Burns easily, tans poorly.\n* Type III: Darker white skin; Tans after initial burn.\n* Type IV: Light brown skin; Burns minimally, tans easily.\n* Type V: Brown skin; Rarely burns, tans darkly easily.\n* Type VI: Dark brown or black skin; Never burns, always tans darkly.', 'unitOfMeasure': 'participants'}, {'title': 'Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)', 'classes': [{'title': '2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '58', 'groupId': 'BG008'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': "The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.", 'unitOfMeasure': 'participants'}, {'title': 'Patient-Reported Submental Fat Rating Scale (PR-SMFRS)', 'classes': [{'title': '2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '56', 'groupId': 'BG008'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'The PR-SMFRS is based on the participant\'s response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.', 'unitOfMeasure': 'participants'}, {'title': 'Subject Self Rating Scale (SSRS)', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '33', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': "The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.", 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-06', 'studyFirstSubmitDate': '2013-10-30', 'resultsFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-12', 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Pain Visual Analog Scale Scores', 'timeFrame': 'Baseline and Day 84', 'description': 'Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).'}, {'measure': 'Change From Baseline in Pain Assessment Using McGill Pain Questionnaire', 'timeFrame': 'Baseline (predose) and Day 84', 'description': 'Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).'}, {'measure': 'Swelling Grading Scale Scores', 'timeFrame': 'Day 84', 'description': 'The following grading system was used for the assessment of swelling:\n\n* Swelling/edema absent (0)\n* Minimal swelling/edema contained within treatment area (1)\n* Modest swelling/edema contained within treatment area (2)\n* Substantial swelling/edema contained within treatment area (3)\n* Swelling/edema of the neck and face beyond the treatment area (4)'}, {'measure': 'Bruising Grading Scale Scores', 'timeFrame': 'Day 84', 'description': 'The following grading system was used for the assessment of bruising:\n\n* Bruising absent (0)\n* Bruising associated with 1 to 3 needle insertion points (1)\n* Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)\n* Bruising covering the entire treatment area but contained within the treatment area (3)\n* Bruising of the neck and face beyond the treatment area (4)'}, {'measure': 'Induration Grading Scale Scores', 'timeFrame': 'Day 84', 'description': 'The following grading system was used for the assessment of induration:\n\n* Induration absent to minimal (0)\n* Induration associated with at least approximately 30% of the treatment area (1)\n* Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)\n* Induration covering the entire treatment area but contained within the treatment area (3)\n* Induration of the neck and face beyond the treatment area (4)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)', 'timeFrame': 'Baseline and Day 84', 'description': "The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)', 'timeFrame': 'Baseline and Day 84', 'description': 'The PR-SMFRS is based on the participant\'s response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Subject Self Rating Scale (SSRS)', 'timeFrame': 'Baseline and Day 84', 'description': "The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Submental Skin Laxity Grades (SMSLG)', 'timeFrame': 'Baseline and Day 84', 'description': 'Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Submental Fat Thickness', 'timeFrame': 'Baseline and Day 84', 'description': 'Submental thickness was measured using caliper devices.'}, {'measure': 'Patient Experience Questions', 'timeFrame': 'Day 84', 'description': 'Participants were asked to complete 3 patient experience questions, each answered as Yes or No:\n\nGiven your experience in this study:\n\n1. Would you recommend this procedure to a friend?\n2. Would you agree to receive additional treatments?\n3. Has the treatment you received in this study affected your normal activities?\n\nThe percentage of participants answering Yes on each question is reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Moderate or Severe Submental Fullness']}, 'referencesModule': {'references': [{'pmid': '27787269', 'type': 'DERIVED', 'citation': 'Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.', 'detailedDescription': 'This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.\n\nParticipants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)\n2. Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)\n3. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².\n4. Acceptable skin laxity as determined by the investigator\n5. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.\n6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)\n7. Signed informed consent obtained before any study-specific procedure is performed.\n\nExclusion Criteria:\n\n1. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area\n2. Absence of clinically significant health problems\n3. Body mass index \\> 40.0 kg/m² as determined prior to randomization.\n4. History of drug or alcohol abuse."}, 'identificationModule': {'nctId': 'NCT02007434', 'briefTitle': 'Patient Experience Study of Deoxycholic Acid Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kythera Biopharmaceuticals'}, 'officialTitle': 'A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area', 'orgStudyIdInfo': {'id': 'ATX-101-13-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paradigm 1 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline CR-SMFRS grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Deoxycholic Acid Injection', 'Other: Cold Compress']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Paradigm 1/ Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Placebo', 'Other: Cold Compress']}, {'type': 'EXPERIMENTAL', 'label': 'Paradigm 2 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Deoxycholic Acid Injection', 'Other: Cold Compress', 'Drug: Lidocaine / Epinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Paradigm 2 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Placebo', 'Other: Cold Compress', 'Drug: Lidocaine / Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Paradigm 3 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Deoxycholic Acid Injection', 'Other: Cold Compress', 'Drug: Lidocaine / Epinephrine', 'Drug: Loratadine', 'Drug: Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Paradigm 3 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Placebo', 'Other: Cold Compress', 'Drug: Lidocaine / Epinephrine', 'Drug: Loratadine', 'Drug: Ibuprofen']}, {'type': 'EXPERIMENTAL', 'label': 'Paradigm 4 / Deoxycholic Acid Injection', 'description': 'Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Deoxycholic Acid Injection', 'Other: Cold Compress', 'Drug: Lidocaine / Epinephrine', 'Drug: Loratadine', 'Drug: Ibuprofen', 'Other: Compression Chin Strap']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Paradigm 4 / Placebo', 'description': 'Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.', 'interventionNames': ['Drug: Placebo', 'Other: Cold Compress', 'Drug: Lidocaine / Epinephrine', 'Drug: Loratadine', 'Drug: Ibuprofen', 'Other: Compression Chin Strap']}], 'interventions': [{'name': 'Deoxycholic Acid Injection', 'type': 'DRUG', 'otherNames': ['ATX-101', 'Kybella'], 'description': 'Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.', 'armGroupLabels': ['Paradigm 1 / Deoxycholic Acid Injection', 'Paradigm 2 / Deoxycholic Acid Injection', 'Paradigm 3 / Deoxycholic Acid Injection', 'Paradigm 4 / Deoxycholic Acid Injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Phosphate buffered saline placebo for injection', 'armGroupLabels': ['Paradigm 1/ Placebo', 'Paradigm 2 / Placebo', 'Paradigm 3 / Placebo', 'Paradigm 4 / Placebo']}, {'name': 'Cold Compress', 'type': 'OTHER', 'description': 'A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.', 'armGroupLabels': ['Paradigm 1 / Deoxycholic Acid Injection', 'Paradigm 1/ Placebo', 'Paradigm 2 / Deoxycholic Acid Injection', 'Paradigm 2 / Placebo', 'Paradigm 3 / Deoxycholic Acid Injection', 'Paradigm 3 / Placebo', 'Paradigm 4 / Deoxycholic Acid Injection', 'Paradigm 4 / Placebo']}, {'name': 'Lidocaine / Epinephrine', 'type': 'DRUG', 'description': 'Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.', 'armGroupLabels': ['Paradigm 2 / Deoxycholic Acid Injection', 'Paradigm 2 / Placebo', 'Paradigm 3 / Deoxycholic Acid Injection', 'Paradigm 3 / Placebo', 'Paradigm 4 / Deoxycholic Acid Injection', 'Paradigm 4 / Placebo']}, {'name': 'Loratadine', 'type': 'DRUG', 'description': 'Loratadine 10 mg orally from Day -7 until Day 7', 'armGroupLabels': ['Paradigm 3 / Deoxycholic Acid Injection', 'Paradigm 3 / Placebo', 'Paradigm 4 / Deoxycholic Acid Injection', 'Paradigm 4 / Placebo']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.', 'armGroupLabels': ['Paradigm 3 / Deoxycholic Acid Injection', 'Paradigm 3 / Placebo', 'Paradigm 4 / Deoxycholic Acid Injection', 'Paradigm 4 / Placebo']}, {'name': 'Compression Chin Strap', 'type': 'OTHER', 'description': 'A compression chin strap was applied 15 minutes after dosing for at least 24 hours.', 'armGroupLabels': ['Paradigm 4 / Deoxycholic Acid Injection', 'Paradigm 4 / Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Frederick Beddingfield, III, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kythera Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}