Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-04 @ 2:53 PM
Study NCT ID:
NCT03915067
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BOTOX® for the Treatment of Platysma Prominence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.', 'description': 'All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 57, 'otherNumAffected': 10, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 6, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 55, 'otherNumAffected': 8, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'INJECTION SITE BRUISING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'INJECTION SITE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'THROMBOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '21.0'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '88.9'}, {'value': '88.2', 'groupId': 'OG002', 'lowerLimit': '79.4', 'upperLimit': '97.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.8', 'ciLowerLimit': '51.5', 'ciUpperLimit': '80.1', 'pValueComment': 'P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.2', 'ciLowerLimit': '63.6', 'ciUpperLimit': '88.9', 'pValueComment': 'P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': "The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study drug up to end of study (up to Day 120)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention.'}, {'type': 'PRIMARY', 'title': 'Pulse Rate at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'spread': '10.77', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '9.77', 'groupId': 'OG001'}, {'value': '73.6', 'spread': '10.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats per minute (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '8.19', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '6.76', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '13.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 7', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '7.96', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '10.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 14', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '11.57', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.09', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '10.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 30', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '11.14', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.24', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '11.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 60', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '8.76', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '9.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 90', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '12.39', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '9.24', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '11.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 120', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Systolic and Diastolic Blood Pressure (BP) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '116.6', 'spread': '12.62', 'groupId': 'OG000'}, {'value': '119.7', 'spread': '14.96', 'groupId': 'OG001'}, {'value': '120.4', 'spread': '13.38', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '77.2', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '9.26', 'groupId': 'OG001'}, {'value': '77.6', 'spread': '8.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic BP at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '1.2', 'spread': '11.49', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '13.37', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '11.14', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.43', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '8.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 7', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic BP at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.29', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '13.27', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '10.17', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '8.69', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '7.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 14', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic BP at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '13.71', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '9.56', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '8.77', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '9.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 30', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic BP at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '14.49', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '15.00', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.03', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '9.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 60', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic BP at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '1.4', 'spread': '11.40', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '11.62', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '11.89', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '7.14', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '10.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 90', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic BP at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '0.6', 'spread': '12.05', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '14.11', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '10.27', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '9.92', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '10.43', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '9.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 120', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Respiratory Rate at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '15.6', 'spread': '2.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths per minute (breaths/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.80', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '1.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 7', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '1.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 14', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '1.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 30', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate at Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 60', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '2.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 90', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate at Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 120', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'OG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '28.6'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '87.3'}, {'value': '88.2', 'groupId': 'OG002', 'lowerLimit': '79.4', 'upperLimit': '97.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.9', 'ciLowerLimit': '42.3', 'ciUpperLimit': '73.5', 'pValueComment': 'P-value was derived from CMH model stratified by investigator site and P-APPS at Day 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70.2', 'ciLowerLimit': '56.4', 'ciUpperLimit': '84.1', 'pValueComment': 'P-value derived from CMH model stratified by investigator site and P-APPS at Day 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'FG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'FG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'Modified Intent-to-treat (mITT) Population', 'comment': 'mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Safety Population', 'comment': 'Safety population included all participants who were administered study intervention.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Covid-19 Related Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Randomized With Incorrect C-APPS', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participant flow and all-cause mortality tables are based on all participants randomized on Day 1. Adverse events are reported for safety population, which included all participants who were administered study intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'BG001', 'title': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'BG002', 'title': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '9.59', 'groupId': 'BG000'}, {'value': '51.8', 'spread': '9.16', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '10.21', 'groupId': 'BG002'}, {'value': '50.0', 'spread': '9.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-12', 'size': 5218915, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-11T12:05', 'hasProtocol': True}, {'date': '2020-05-22', 'size': 654197, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-11T12:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'dispFirstSubmitDate': '2021-04-12', 'completionDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2019-03-29', 'dispFirstSubmitQcDate': '2021-04-12', 'resultsFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'dispFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-11', 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)', 'timeFrame': 'Day 14', 'description': "The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis."}, {'measure': 'Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'From the first dose of study drug up to end of study (up to Day 120)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.'}, {'measure': 'Pulse Rate at Baseline', 'timeFrame': 'Baseline (Day 1)', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Change From Baseline in Pulse Rate at Day 7', 'timeFrame': 'Baseline; Day 7', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Change From Baseline in Pulse Rate at Day 14', 'timeFrame': 'Baseline; Day 14', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Change From Baseline in Pulse Rate at Day 30', 'timeFrame': 'Baseline; Day 30', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Change From Baseline in Pulse Rate at Day 60', 'timeFrame': 'Baseline; Day 60', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Change From Baseline in Pulse Rate at Day 90', 'timeFrame': 'Baseline; Day 90', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Change From Baseline in Pulse Rate at Day 120', 'timeFrame': 'Baseline; Day 120', 'description': 'Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.'}, {'measure': 'Systolic and Diastolic Blood Pressure (BP) at Baseline', 'timeFrame': 'Baseline (Day 1)', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Change From Baseline in Systolic and Diastolic BP at Day 7', 'timeFrame': 'Baseline; Day 7', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Change From Baseline in Systolic and Diastolic BP at Day 14', 'timeFrame': 'Baseline; Day 14', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Change From Baseline in Systolic and Diastolic BP at Day 30', 'timeFrame': 'Baseline; Day 30', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Change From Baseline in Systolic and Diastolic BP at Day 60', 'timeFrame': 'Baseline; Day 60', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Change From Baseline in Systolic and Diastolic BP at Day 90', 'timeFrame': 'Baseline; Day 90', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Change From Baseline in Systolic and Diastolic BP at Day 120', 'timeFrame': 'Baseline; Day 120', 'description': 'Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.'}, {'measure': 'Respiratory Rate at Baseline', 'timeFrame': 'Baseline (Day 1)', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}, {'measure': 'Change From Baseline in Respiratory Rate at Day 7', 'timeFrame': 'Baseline; Day 7', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}, {'measure': 'Change From Baseline in Respiratory Rate at Day 14', 'timeFrame': 'Baseline; Day 14', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}, {'measure': 'Change From Baseline in Respiratory Rate at Day 30', 'timeFrame': 'Baseline; Day 30', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}, {'measure': 'Change From Baseline in Respiratory Rate at Day 60', 'timeFrame': 'Baseline; Day 60', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}, {'measure': 'Change From Baseline in Respiratory Rate at Day 90', 'timeFrame': 'Baseline; Day 90', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}, {'measure': 'Change From Baseline in Respiratory Rate at Day 120', 'timeFrame': 'Baseline; Day 120', 'description': 'Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)', 'timeFrame': 'Day 14', 'description': 'The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platysma Prominence']}, 'referencesModule': {'references': [{'pmid': '40704633', 'type': 'DERIVED', 'citation': 'Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31.'}, {'pmid': '38640068', 'type': 'DERIVED', 'citation': 'Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period\n* A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:\n\n 1. Not a woman of childbearing potential (WOCBP) OR\n 2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol\n\nExclusion Criteria:\n\n* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function\n* Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)\n* Anticipated need for surgery or overnight hospitalization during the study\n* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study\n* Females who are pregnant, nursing, or planning a pregnancy during the study\n* Known immunization or hypersensitivity to any botulinum toxin serotype\n* History of alcohol or drug abuse within 12 months of the study\n* Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck"}, 'identificationModule': {'nctId': 'NCT03915067', 'briefTitle': 'BOTOX® for the Treatment of Platysma Prominence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence', 'orgStudyIdInfo': {'id': '1936-201-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BOTOX® Low Dose', 'description': 'Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.', 'interventionNames': ['Drug: BOTOX® purified neurotoxin complex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BOTOX® High Dose', 'description': 'Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.', 'interventionNames': ['Drug: BOTOX® purified neurotoxin complex']}], 'interventions': [{'name': 'BOTOX® purified neurotoxin complex', 'type': 'DRUG', 'otherNames': ['Botulinum toxin type A purified neurotoxin complex'], 'description': 'BOTOX® superficial intramuscular injections.', 'armGroupLabels': ['BOTOX® High Dose', 'BOTOX® Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo injections.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Skin Care and Laser Physicians of Beverly Hills /ID# 236518', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33146-1837', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Research Institute LLC /ID# 238126', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'DeNova Research /ID# 238165', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21030', 'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'facility': 'MD Laser Skin & Vein /ID# 234532', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '10549-3028', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Practice of Brian S. Biesman MD PLLC /ID# 234461', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Plastic Surgery Institute /ID# 236528', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Humphrey Cosmetic Dermatology /ID# 236591', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pacific Derm /ID# 238236', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L7N 3N2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermetics Cosmetic Dermatology /ID# 236899', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'M5R 3N8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sweat Clinics of Canada /ID# 236590', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'L4L 8E2', 'city': 'Woodbridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bertucci MedSpa Inc. /ID# 236523', 'geoPoint': {'lat': 43.78341, 'lon': -79.59962}}], 'overallOfficials': [{'name': 'ALLERGAN INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}