Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT04994535
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, '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 and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 6, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 7, 'seriousNumAtRisk': 208, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'ADNEXA UTERI CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': "Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'comment': 'NA = Value not estimable due to insufficient number of participants with estimated events after using multiple imputation for missing data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '37.8'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.9', 'ciLowerLimit': '24.5', 'ciUpperLimit': '37.4', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': "The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.\n\nThe Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'PRIMARY', 'title': "Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.3'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '33.8', 'upperLimit': '48.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.9', 'ciLowerLimit': '31.3', 'ciUpperLimit': '46.4', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': "The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'PRIMARY', 'title': "Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.7'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '33.5', 'upperLimit': '48.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.9', 'ciLowerLimit': '29.1', 'ciUpperLimit': '44.7', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.3'}, {'value': '48.3', 'groupId': 'OG001', 'lowerLimit': '41.3', 'upperLimit': '55.3'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '5.8'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '36.9', 'upperLimit': '50.7'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.3'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '30.8'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.9'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '20.1'}]}]}, {'title': 'Day 120', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '4.7'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '18.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': "The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '8.2'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '40.2', 'upperLimit': '54.1'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '8.8'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '34.2', 'upperLimit': '47.8'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '10.6'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '35.2'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.2'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '26.3'}]}]}, {'title': 'Day 120', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '6.3'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '21.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '16.5'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '68.9'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.2', 'ciLowerLimit': '42.0', 'ciUpperLimit': '58.3', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).', 'unitOfMeasure': 'percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '28.9'}, {'value': '50.2', 'groupId': 'OG001', 'lowerLimit': '43.3', 'upperLimit': '57.1'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.1', 'ciLowerLimit': '18.1', 'ciUpperLimit': '36.1', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '19.2'}, {'value': '50.2', 'groupId': 'OG001', 'lowerLimit': '43.3', 'upperLimit': '57.1'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.8', 'ciLowerLimit': '27.4', 'ciUpperLimit': '44.2', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (SE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '-3.4', 'pValueComment': 'P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Impacts scale assesses the psychosocial impact due to the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '25.7'}, {'value': '76.9', 'groupId': 'OG001', 'lowerLimit': '71.0', 'upperLimit': '82.7'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '24.3'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '66.4', 'upperLimit': '78.8'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '25.1'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '62.0'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '22.7'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': '50.9'}]}]}, {'title': 'Day 120', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '19.9'}, {'value': '33.9', 'groupId': 'OG001', 'lowerLimit': '27.4', 'upperLimit': '40.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': "The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '26.6'}, {'value': '79.3', 'groupId': 'OG001', 'lowerLimit': '73.6', 'upperLimit': '84.9'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '28.6'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '80.0'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '26.5'}, {'value': '65.2', 'groupId': 'OG001', 'lowerLimit': '58.6', 'upperLimit': '71.9'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '24.2'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '46.6', 'upperLimit': '60.7'}]}]}, {'title': 'Day 120', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '24.3'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '49.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '8.4'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '55.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.9', 'ciLowerLimit': '34.8', 'ciUpperLimit': '51.0', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '16.6'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '68.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.4', 'ciLowerLimit': '40.8', 'ciUpperLimit': '58.1', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) are estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '26.4'}, {'value': '49.4', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '56.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.8', 'ciLowerLimit': '19.4', 'ciUpperLimit': '38.2', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '16.6'}, {'value': '47.8', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '55.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.9', 'ciLowerLimit': '27.2', 'ciUpperLimit': '44.6', 'pValueComment': 'P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (SE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-3.7', 'pValueComment': 'P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Impacts scale assesses the psychosocial impact due to the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'OG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'classes': [{'title': 'Day 30', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (SE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '-3.7', 'pValueComment': 'P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Day 30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (SE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '-3.6', 'pValueComment': 'P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'groupDescription': 'Day 60', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (SE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '-2.8', 'pValueComment': 'P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Day 90', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 30, 60, and 90', 'description': 'The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'FG001', 'title': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 426 participants were enrolled and randomized into the study (ITT Population); 209 to BOTOX and 217 to placebo. A total of 208 participants were treated with BOTOX and 216 participants were treated with placebo (Safety Analysis Set). A total of 381 participants were included in the modified ITT (mITT) Population; 186 to BOTOX and 195 to placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.', 'preAssignmentDetails': 'The ITT Population included all randomized participants; the mITT Population included all randomized participants with a baseline summary score ≥ 19 on the ANLFQ: Impacts questionnaire. The Safety Analysis Set included all participants who were treated with at least 1 dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo was injected into the platysma muscle on Day 1'}, {'id': 'BG001', 'title': 'BOTOX (onabotulinumtoxinA)', 'description': 'BOTOX (onabotulinumtoxinA) was injected into the platysma muscle on Day 1'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '10.18', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '9.57', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '9.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analyses were performed on the ITT population, consisting of all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-22', 'size': 2630436, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-12T09:52', 'hasProtocol': True}, {'date': '2023-06-20', 'size': 487914, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-12T09:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2021-07-29', 'resultsFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-24', 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Enrollment 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.'}, {'measure': "Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14", 'timeFrame': 'Day 14', 'description': "The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.\n\nThe Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme."}, {'measure': "Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14", 'timeFrame': 'Day 14', 'description': "The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme."}, {'measure': "Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14", 'timeFrame': 'Day 14', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.'}], 'secondaryOutcomes': [{'measure': "Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': "The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme."}, {'measure': "Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.'}, {'measure': 'Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).'}, {'measure': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14", 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).'}, {'measure': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14", 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).'}, {'measure': 'Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Impacts scale assesses the psychosocial impact due to the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.'}, {'measure': "Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': "The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme."}, {'measure': "Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120", 'timeFrame': 'Day 14, 30, 60, 90, and 120', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.'}, {'measure': "Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14", 'timeFrame': 'Day 14', 'description': 'The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.'}, {'measure': 'Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14', 'timeFrame': 'Day 14', 'description': 'The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).'}, {'measure': "Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14", 'timeFrame': 'Day 14', 'description': 'The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).'}, {'measure': 'Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90', 'timeFrame': 'Days 30, 60, and 90', 'description': 'The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platysma Prominence', 'OnabotulinumtoxinA', 'BOTOX'], 'conditions': ['Platysma Prominence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M21-310', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.\n\nStudy doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.\n\nParticipants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.\n\nParticipants will attend regular monthly visits during the study at the study site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures\n* Are willing and able to comply with procedures required in the protocol\n* Adult male or female, at least 18 years old at the time of signing the informed consent\n* Good health as determined by medical history, physical examination, vital signs, and investigator's judgment\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* Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study\n* Known immunization or hypersensitivity to any botulinum toxin serotype\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months\n* Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)\n* Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest"}, 'identificationModule': {'nctId': 'NCT04994535', 'briefTitle': 'A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence', 'orgStudyIdInfo': {'id': 'M21-310'}, 'secondaryIdInfos': [{'id': '2021-000240-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOTOX', 'description': 'BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1', 'interventionNames': ['Drug: OnabotulinumtoxinA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be injected into the platysma muscle on Day 1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'DRUG', 'otherNames': ['BOTOX'], 'description': 'Injection', 'armGroupLabels': ['BOTOX']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Derm Ctr /ID# 249905', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90025-1708', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Westside Aesthetics /ID# 231196', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Skin Care and Laser 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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': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}