Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT05419505
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2022-06-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000933', 'term': 'Antifibrinolytic Agents'}], 'ancestors': [{'id': 'D050299', 'term': 'Fibrin Modulating Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006490', 'term': 'Hemostatics'}, {'id': 'D003029', 'term': 'Coagulants'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@endo.com', 'phone': '800-462-3636', 'title': 'Clinical Operations', 'organization': 'Endo Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was halted before the predetermined sample size was enrolled, therefore, was not adequately powered to draw conclusions or to make comparisons between cohorts.'}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 (after dose) through Day 180', 'description': "Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.", 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mL).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 0, 'otherNumAffected': 22, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: CCH-aaes Dose Evaluation-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 0, 'otherNumAffected': 22, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 0, 'otherNumAffected': 13, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 0, 'otherNumAffected': 13, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 0, 'otherNumAffected': 5, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 0, 'otherNumAffected': 5, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 0, 'otherNumAffected': 7, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 0, 'otherNumAffected': 7, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 0, 'otherNumAffected': 10, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 0, 'otherNumAffected': 10, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 0, 'otherNumAffected': 19, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 0, 'otherNumAffected': 19, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 0, 'otherNumAffected': 7, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 0, 'otherNumAffected': 6, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR)', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 0, 'otherNumAffected': 7, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR)', 'description': 'Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 0, 'otherNumAffected': 7, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Cohort 1: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 1.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'Cohort 2: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 2.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'Cohort 3: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 3.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG019', 'title': 'Cohort 4: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 4.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG020', 'title': 'Cohort 5: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 5.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG021', 'title': 'Cohort 6: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 6.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG022', 'title': 'Cohort 7a: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7a.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG023', 'title': 'Cohort 7b: Systemic/Non-ISR AEs', 'description': 'Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7b.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 10}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 19}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 19}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site haemorrhage', 'notes': 'All AEs classified as injection site hemorrhage (preferred MedDRA term) for reporting purposes were identified with the verbatim term "ecchymosis" by investigators during the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0, 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'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \\[mg\\]) but maintaining the labeled concentration (0.23 mg/milliliters \\[mL\\]).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG001', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG002', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.'}, {'id': 'OG003', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.'}, {'id': 'OG004', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG005', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.\n\nParticipants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.'}, {'id': 'OG006', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG007', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '69.62', 'upperLimit': '98.83'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '57.19'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '71.64'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '4.33', 'upperLimit': '77.72'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '13.70', 'upperLimit': '78.80'}, {'value': '63.2', 'groupId': 'OG005', 'lowerLimit': '38.36', 'upperLimit': '83.71'}, {'value': '33.3', 'groupId': 'OG006', 'lowerLimit': '4.33', 'upperLimit': '77.72'}, {'value': '33.3', 'groupId': 'OG007', 'lowerLimit': '4.33', 'upperLimit': '77.72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)', 'description': 'The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes.\n\nThe investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side.\n\nPercentages are based on the number of participants with an assessment at specified timepoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG001', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG002', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.'}, {'id': 'OG003', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.'}, {'id': 'OG004', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG005', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.\n\nParticipants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.'}, {'id': 'OG006', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG007', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}], 'classes': [{'title': 'Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '59.72', 'upperLimit': '94.81'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '45.45'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '52.18'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '9.90', 'upperLimit': '81.59'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '12.16', 'upperLimit': '73.76'}, {'value': '44.4', 'groupId': 'OG005', 'lowerLimit': '21.53', 'upperLimit': '69.24'}, {'value': '16.7', 'groupId': 'OG006', 'lowerLimit': '0.42', 'upperLimit': '64.12'}, {'value': '42.9', 'groupId': 'OG007', 'lowerLimit': '9.90', 'upperLimit': '81.59'}]}]}, {'title': 'Follow-up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '69.62', 'upperLimit': '98.83'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '57.19'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '71.64'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '4.33', 'upperLimit': '77.72'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '13.70', 'upperLimit': '78.80'}, {'value': '63.2', 'groupId': 'OG005', 'lowerLimit': '38.36', 'upperLimit': '83.71'}, {'value': '33.3', 'groupId': 'OG006', 'lowerLimit': '4.33', 'upperLimit': '77.72'}, {'value': '33.3', 'groupId': 'OG007', 'lowerLimit': '4.33', 'upperLimit': '77.72'}]}]}, {'title': 'Follow-up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.71', 'upperLimit': '63.65'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '13.86', 'upperLimit': '68.42'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '5.27', 'upperLimit': '85.34'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '3.67', 'upperLimit': '70.96'}, {'value': '10.0', 'groupId': 'OG004', 'lowerLimit': '0.25', 'upperLimit': '44.50'}, {'value': '31.6', 'groupId': 'OG005', 'lowerLimit': '12.58', 'upperLimit': '56.55'}, {'value': '40.0', 'groupId': 'OG006', 'lowerLimit': '5.27', 'upperLimit': '85.34'}, {'value': '42.9', 'groupId': 'OG007', 'lowerLimit': '9.90', 'upperLimit': '81.59'}]}]}, {'title': 'Follow-up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.91', 'upperLimit': '34.91'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '2.28', 'upperLimit': '51.78'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '52.18'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '0.36', 'upperLimit': '57.87'}, {'value': '10.0', 'groupId': 'OG004', 'lowerLimit': '0.25', 'upperLimit': '44.50'}, {'value': '21.1', 'groupId': 'OG005', 'lowerLimit': '6.05', 'upperLimit': '45.57'}, {'value': '16.7', 'groupId': 'OG006', 'lowerLimit': '0.42', 'upperLimit': '64.12'}, {'value': '71.4', 'groupId': 'OG007', 'lowerLimit': '29.04', 'upperLimit': '96.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)', 'description': 'The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.\n\nThe investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit.\n\nPercentages are based on the number of participants with an assessment at specified timepoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG001', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG002', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.'}, {'id': 'OG003', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.'}, {'id': 'OG004', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG005', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.\n\nParticipants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.'}, {'id': 'OG006', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG007', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}], 'classes': [{'title': 'Day 22 Left Buttock (Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '21.82', 'upperLimit': '65.98'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '27.67', 'upperLimit': '84.83'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '12.16', 'upperLimit': '73.76'}, {'value': '85.7', 'groupId': 'OG006', 'lowerLimit': '42.13', 'upperLimit': '99.64'}]}]}, {'title': 'Day 22 Right Buttock (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '34.02', 'upperLimit': '78.18'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '34.89', 'upperLimit': '90.08'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '12.16', 'upperLimit': '73.76'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Day 43 Left Buttock (Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '47.82', 'upperLimit': '88.72'}, {'value': '84.6', 'groupId': 'OG001', 'lowerLimit': '54.55', 'upperLimit': '98.08'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '35.88', 'upperLimit': '99.58'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '29.93', 'upperLimit': '92.51'}, {'value': '44.4', 'groupId': 'OG005', 'lowerLimit': '21.53', 'upperLimit': '69.24'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Day 43 Right Buttock (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '52.83', 'upperLimit': '91.78'}, {'value': '76.9', 'groupId': 'OG001', 'lowerLimit': '46.19', 'upperLimit': '94.96'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '54.07', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '29.93', 'upperLimit': '92.51'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '26.02', 'upperLimit': '73.98'}, {'value': '40.0', 'groupId': 'OG006', 'lowerLimit': '5.27', 'upperLimit': '85.34'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.94', 'upperLimit': '100'}]}]}, {'title': 'Day 64 Left Buttock (Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG006', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Day 64 Right Buttock (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG006', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Day 90 (Follow-up) Left Buttock (Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '18.11', 'upperLimit': '61.56'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '34.75', 'upperLimit': '93.33'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.8', 'upperLimit': '95.67'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '13.70', 'upperLimit': '78.80'}, {'value': '27.8', 'groupId': 'OG005', 'lowerLimit': '9.69', 'upperLimit': '53.48'}, {'value': '85.7', 'groupId': 'OG006', 'lowerLimit': '42.13', 'upperLimit': '99.64'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Day 90 (Follow-up) Right Buttock (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '25.71', 'upperLimit': '70.22'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '44.39', 'upperLimit': '97.48'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '35.88', 'upperLimit': '99.58'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '13.70', 'upperLimit': '78.80'}, {'value': '38.9', 'groupId': 'OG005', 'lowerLimit': '17.30', 'upperLimit': '64.25'}, {'value': '71.4', 'groupId': 'OG006', 'lowerLimit': '29.04', 'upperLimit': '96.33'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Day 135 (Follow-up) Left Buttock (Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '16.29', 'upperLimit': '61.64'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '58.72', 'upperLimit': '99.77'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '11.81', 'upperLimit': '88.19'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '2.81', 'upperLimit': '60.01'}, {'value': '22.2', 'groupId': 'OG005', 'lowerLimit': '6.41', 'upperLimit': '47.64'}, {'value': '83.3', 'groupId': 'OG006', 'lowerLimit': '35.88', 'upperLimit': '99.58'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '54.07', 'upperLimit': '100'}]}]}, {'title': 'Day 135 (Follow-up) Right Buttock (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '24.45', 'upperLimit': '71.14'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '48.22', 'upperLimit': '97.72'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '2.81', 'upperLimit': '60.01'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '13.34', 'upperLimit': '59.01'}, {'value': '66.7', 'groupId': 'OG006', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '83.3', 'groupId': 'OG007', 'lowerLimit': '35.88', 'upperLimit': '99.58'}]}]}, {'title': 'Day 180 (End of Study) Left Buttock (Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '16.29', 'upperLimit': '61.64'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '71.51', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '11.81', 'upperLimit': '88.19'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '0.28', 'upperLimit': '48.25'}, {'value': '17.6', 'groupId': 'OG005', 'lowerLimit': '3.80', 'upperLimit': '43.43'}, {'value': '66.7', 'groupId': 'OG006', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '83.3', 'groupId': 'OG007', 'lowerLimit': '35.88', 'upperLimit': '99.58'}]}]}, {'title': 'Day 180 (End of Study) Right Buttock (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '16.29', 'upperLimit': '61.64'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '48.22', 'upperLimit': '97.72'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '0.28', 'upperLimit': '48.25'}, {'value': '41.2', 'groupId': 'OG005', 'lowerLimit': '18.44', 'upperLimit': '67.08'}, {'value': '66.7', 'groupId': 'OG006', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '83.3', 'groupId': 'OG007', 'lowerLimit': '35.88', 'upperLimit': '99.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts', 'description': 'The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment.\n\nThe investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock.\n\nA 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area.\n\nPercentages are based on the number of participants with an assessment at specified timepoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid assessment at a treatment area after an injection of CCH-aaes.\n\nFor Cohort 7a, on Day 22, I-GAIS was only assessed for the investigational buttock (left buttock) and for Cohort 7b, on Day 22, I-GAIS was only assessed for the control buttock (right buttock).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG001', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG002', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.'}, {'id': 'OG003', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.'}, {'id': 'OG004', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG005', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.\n\nParticipants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.'}, {'id': 'OG006', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'OG007', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}], 'classes': [{'title': 'Left Buttock (Test)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.56', 'upperLimit': '100'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '75.29', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '59.04', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '69.15', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '82.35', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '59.04', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}, {'title': 'Right Buttock (Control)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.56', 'upperLimit': '100'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '75.29', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '47.82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '59.04', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '69.15', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '82.35', 'upperLimit': '100'}, {'value': '85.7', 'groupId': 'OG006', 'lowerLimit': '54.07', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '59.04', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 (after dose) through Day 180', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control).\n\nA summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 injection of CCH-aaes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \\[mg\\]) but maintaining the labeled concentration (0.23 mg/milliliters \\[mL\\]).\n\nControl: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'FG001', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).\n\nControl: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'FG002', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.\n\nControl: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.'}, {'id': 'FG003', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.\n\nControl" Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.'}, {'id': 'FG004', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.\n\nControl: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'FG005', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.\n\nControl: Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.'}, {'id': 'FG006', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nControl: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'FG007', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent', 'description': 'Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nControl: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Left and right buttock', 'groupId': 'FG000', 'numUnits': '44', 'numSubjects': '22'}, {'comment': 'Left and right buttock', 'groupId': 'FG001', 'numUnits': '28', 'numSubjects': '14'}, {'comment': 'Left and right buttock', 'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '5'}, {'comment': 'Left and right buttock', 'groupId': 'FG003', 'numUnits': '14', 'numSubjects': '7'}, {'comment': 'Left and right buttock', 'groupId': 'FG004', 'numUnits': '20', 'numSubjects': '10'}, {'comment': 'Left and right buttock', 'groupId': 'FG005', 'numUnits': '38', 'numSubjects': '19'}, {'comment': 'Left and right buttock', 'groupId': 'FG006', 'numUnits': '14', 'numSubjects': '7'}, {'comment': 'Left and right buttock', 'groupId': 'FG007', 'numUnits': '14', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '38', 'numSubjects': '19'}, {'groupId': 'FG001', 'numUnits': '22', 'numSubjects': '11'}, {'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '5'}, {'groupId': 'FG003', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG004', 'numUnits': '18', 'numSubjects': '9'}, {'groupId': 'FG005', 'numUnits': '34', 'numSubjects': '17'}, {'groupId': 'FG006', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG007', 'numUnits': '12', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG004', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG005', 'numUnits': '4', 'numSubjects': '2'}, {'groupId': 'FG006', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG007', 'numUnits': '2', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'buttock', 'preAssignmentDetails': "Ninety-one participants were enrolled in this split-person study to compare different collagenase clostridium histolyticum-aaes (CCH-aaes) treatment regimens. Participants were administered study intervention in a split-buttock arrangement, with each participant's right buttock serving as the control to their assigned intervention administered to the left buttock (test)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '91', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \\[mg\\]) but maintaining the labeled concentration (0.23 mg/milliliters \\[mL\\]).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL)'}, {'id': 'BG001', 'title': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'BG002', 'title': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.'}, {'id': 'BG003', 'title': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.'}, {'id': 'BG004', 'title': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'BG005', 'title': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.\n\nParticipants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.'}, {'id': 'BG006', 'title': 'Cohort 7a: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'BG007', 'title': 'Cohort 7b: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.\n\nParticipants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.50', 'spread': '10.698', 'groupId': 'BG000'}, {'value': '44.79', 'spread': '9.125', 'groupId': 'BG001'}, {'value': '44.40', 'spread': '8.503', 'groupId': 'BG002'}, {'value': '34.00', 'spread': '8.699', 'groupId': 'BG003'}, {'value': '46.50', 'spread': '10.179', 'groupId': 'BG004'}, {'value': '47.74', 'spread': '7.225', 'groupId': 'BG005'}, {'value': '37.57', 'spread': '10.967', 'groupId': 'BG006'}, {'value': '38.57', 'spread': '10.549', 'groupId': 'BG007'}, {'value': '43.40', 'spread': '9.998', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '91', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Black or African American', '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': 'White', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '84', 'groupId': 'BG008'}]}]}, {'title': 'Other', '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': 'Multiple', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least 1 injection of CCH-aaes.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-12', 'size': 1899431, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-19T16:35', 'hasProtocol': True}, {'date': '2023-07-21', 'size': 712009, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-19T16:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-06-09', 'resultsFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-04', 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection', 'timeFrame': '3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)', 'description': 'The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes.\n\nThe investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side.\n\nPercentages are based on the number of participants with an assessment at specified timepoint.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS', 'timeFrame': 'Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)', 'description': 'The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome.\n\nThe investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit.\n\nPercentages are based on the number of participants with an assessment at specified timepoint.'}, {'measure': 'Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection', 'timeFrame': 'Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts', 'description': 'The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment.\n\nThe investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock.\n\nA 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area.\n\nPercentages are based on the number of participants with an assessment at specified timepoint.'}, {'measure': 'Percentage of Participants With Injection Site Reactions', 'timeFrame': 'From Day 1 (after dose) through Day 180', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control).\n\nA summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Collagenase Clostridium Histolyticum', 'collagenase clostridium histolyticum-aaes'], 'conditions': ['Edematous Fibrosclerotic Panniculopathy', 'Cellulite']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes \\[CCH-aaes\\]).', 'detailedDescription': 'The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Have a body mass index of 18 to \\<32 kilograms (kg)/meter (m)\\^2 and intends to maintain stable body weight during the study.\n* Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).\n* Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤12.\n* Has a Fitzpatrick Skin Type of I-IV\n* Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study.\n* Be willing and able to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n* Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.\n* Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.\n* Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation.\n* Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study.\n* Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment.\n* Has received treatment with investigational treatment within 30 days before treatment.\n* Has used or intends to use any of the local applications, therapies, injections, or procedures for the treatment of cellulite on either buttock that would restrict study participation.\n* Intends to initiate an intensive sport or exercise program or intensive weight reduction program during the study.\n* Intends to engage in strenuous activity within 48 hours of study intervention administration.\n* Has recently tanned or intends to tan (outdoors or indoors) during the study.\n* Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH.\n* Has any condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.\n* Has participated in a previous investigational study of CCH or received any collagenase treatments at any time prior to treatment in this study for the treatment of cellulite of the buttocks.\n\nIn addition to the applicable aforementioned exclusion criteria, participants enrolling in Cohort 7 will be excluded from study participation if the participant:\n\n* Has any of the following medical conditions:\n\n 1. history of venous or arterial thromboembolism or current thromboembolic disease.\n 2. history of or current renal impairment.\n 3. serum creatinine concentration \\> 1.4 milligram/deciliter at Screening.\n* Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:\n\n 1. concurrently taking combination hormonal contraceptives.\n 2. concurrently undergoing hormone replacement therapy.\n 3. is a current smoker of nicotine or cannabinoids.\n* Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study."}, 'identificationModule': {'nctId': 'NCT05419505', 'acronym': 'APHRODITE', 'briefTitle': 'Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'APHRODITE-1: A Phase 2, Open Label, Self-Controlled Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks in Adult Females', 'orgStudyIdInfo': {'id': 'EN3835-226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: CCH-aaes Dose Evaluation', 'description': 'Participants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: CCH-aaes Concentration Evaluation', 'description': 'Participants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'description': 'Participants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: CCH-aaes Injection Method Evaluation', 'description': 'Participants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'description': 'Participants will be administered CCH-aaes and diluent additive. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'description': 'Participants will be administered CCH-aaes using a different treatment schedule and different doses and concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7: CCH-aaes and Antifibrinolytic Agent', 'description': 'Participants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.', 'interventionNames': ['Drug: CCH-aaes', 'Drug: Antifibrinolytic Agent']}], 'interventions': [{'name': 'CCH-aaes', 'type': 'DRUG', 'otherNames': ['Collagenase clostridium histolyticum-aaes', 'QWO®'], 'description': 'Administered by subcutaneous injection.', 'armGroupLabels': ['Cohort 1: CCH-aaes Dose Evaluation', 'Cohort 2: CCH-aaes Concentration Evaluation', 'Cohort 3: CCH-aaes Injection Depth Evaluation', 'Cohort 4: CCH-aaes Injection Method Evaluation', 'Cohort 5: CCH-aaes and Diluent Additive Evaluation', 'Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation', 'Cohort 7: CCH-aaes and Antifibrinolytic Agent']}, {'name': 'Antifibrinolytic Agent', 'type': 'DRUG', 'description': 'Self-administered by participants enrolled in Cohort 7.', 'armGroupLabels': ['Cohort 7: CCH-aaes and Antifibrinolytic Agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #6', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #4', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #9', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #10', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92075', 'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #7', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #12', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #8', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #13', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #3', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '700006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #2', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #11', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #1', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #5', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}], 'overallOfficials': [{'name': 'David Hernandez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}