Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-07 @ 6:25 PM
Study NCT ID:
NCT03806933
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545476', 'term': 'incobotulinumtoxinA'}, {'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': 'Aesthetic.Trials@merz.com', 'phone': '+49 69 1503 1', 'title': 'Public Disclosure Manager', 'organization': 'Merz Pharmaceuticals GmbH'}, 'certainAgreement': {'otherDetails': 'Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of first treatment up to Day 390', 'description': 'As planned, combined safety data for NT 201 administered in MP and OLEX were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 13, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 11, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 12, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 12, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000', 'lowerLimit': '142', 'upperLimit': '185'}, {'value': '185', 'groupId': 'OG001', 'lowerLimit': '182', 'upperLimit': '205'}, {'value': '210', 'groupId': 'OG002', 'lowerLimit': '182', 'upperLimit': '217'}, {'value': '215', 'groupId': 'OG003', 'lowerLimit': '183', 'upperLimit': '237'}]}]}], 'analyses': [{'pValue': '= 0.881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.51', 'pValueComment': 'P-values were based on Wald Chi-Square tests for hazard ratios.', 'estimateComment': 'Hazard ratio (HR) was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.089', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.05', 'pValueComment': 'P-values were based on Wald Chi-Square tests for hazard ratios.', 'estimateComment': 'HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0035', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.83', 'estimateComment': 'HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-values were based on Wald Chi-Square tests for hazard ratios.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of first treatment up to Day 360', 'description': "Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first treatment up to Day 390', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SES was the subset of all participants who were exposed to study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first treatment up to Day 390', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SES was the subset of all participants who were exposed to study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first treatment up to Day 390', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SES was the subset of all participants who were exposed to study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment Related TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first treatment up to Day 390', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SES was the subset of all participants who were exposed to study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment Related TESAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first treatment up to Day 390', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SES was the subset of all participants who were exposed to study medication.'}, {'type': 'SECONDARY', 'title': 'Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '134'}, {'value': '121', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '149'}, {'value': '129', 'groupId': 'OG002', 'lowerLimit': '122', 'upperLimit': '157'}, {'value': '148', 'groupId': 'OG003', 'lowerLimit': '125', 'upperLimit': '173'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of first treatment up to Day 360', 'description': "Duration of effect was defined as time between treatment and first point in time when score was moderate or severe again. If no effect was observed, duration of effect was set to 0. Effect was defined by a score of none (0) or mild (1) at maximum frown as assessed by investigator according to FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}, {'type': 'SECONDARY', 'title': 'Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '118'}, {'value': '118', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '127'}, {'value': '122', 'groupId': 'OG002', 'lowerLimit': '119', 'upperLimit': '127'}, {'value': '145', 'groupId': 'OG003', 'lowerLimit': '120', 'upperLimit': '149'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of first treatment up to Day 360', 'description': "Duration of effect: time between treatment and first point in time when improvement was less than 2 points again. If no effect was observed, duration of effect was set to 0. Effect: at least a 2-point improvement from baseline at maximum frown as assessed by investigator on the FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '18.1'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '18.4'}, {'value': '16.4', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '28.1'}, {'value': '18.6', 'groupId': 'OG003', 'lowerLimit': '9.7', 'upperLimit': '30.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 180', 'description': "Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CIs for percentage of participants were based on Pearson-clopper method.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '15.9'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '20.5'}, {'value': '19.7', 'groupId': 'OG002', 'lowerLimit': '10.6', 'upperLimit': '31.8'}, {'value': '16.9', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '29.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 180', 'description': "Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '46.0'}, {'value': '43.3', 'groupId': 'OG001', 'lowerLimit': '30.6', 'upperLimit': '56.8'}, {'value': '52.5', 'groupId': 'OG002', 'lowerLimit': '39.3', 'upperLimit': '65.4'}, {'value': '52.5', 'groupId': 'OG003', 'lowerLimit': '39.1', 'upperLimit': '65.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 180', 'description': "Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'OG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '51.0'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '50.1'}, {'value': '52.5', 'groupId': 'OG002', 'lowerLimit': '39.3', 'upperLimit': '65.4'}, {'value': '45.8', 'groupId': 'OG003', 'lowerLimit': '32.7', 'upperLimit': '59.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 180', 'description': "Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 milliliter (mL) injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'FG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'FG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'FG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}], 'periods': [{'title': 'Main Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'Safety Evaluation Set (SES)', 'comment': 'One participant randomized to NT 201 100 U dose group was actually treated with NT 201 20 U. The participant was re-assigned to the Pooled: NT 201 20 U dose group for safety analyses.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'OLEX Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only participants who relapsed to baseline status of their glabellar frown lines (GFL) in the MP and completed the MP had the opportunity to receive optional follow-up treatment; those receiving optional treatment were entered in the OLEX period.', 'groupId': 'FG000', 'numSubjects': '52'}, {'comment': 'Only participants who relapsed to baseline status of their glabellar frown lines (GFL) in the MP and completed the MP had the opportunity to receive optional follow-up treatment; those receiving optional treatment were entered in the OLEX period.', 'groupId': 'FG001', 'numSubjects': '53'}, {'comment': 'Only participants who relapsed to baseline status of their glabellar frown lines (GFL) in the MP and completed the MP had the opportunity to receive optional follow-up treatment; those receiving optional treatment were entered in the OLEX period.', 'groupId': 'FG002', 'numSubjects': '56'}, {'comment': 'Only participants who relapsed to baseline status of their glabellar frown lines (GFL) in the MP and completed the MP had the opportunity to receive optional follow-up treatment; those receiving optional treatment were entered in the OLEX period.', 'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Due to coronavirus disease (COVID) 19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study was conducted at 9 sites in Germany and the United States from 23 January 2019 to 8 October 2020. Out of 256 participants, 15 participants were screen failures and 241 participants were enrolled and randomized in the study. Study had 2 periods: Main Period (MP) and an optional Open-label Extension (OLEX) Period. As planned, combined safety data for MP and OLEX Period was reported.', 'preAssignmentDetails': 'In MP, Stage 1, participants received NT 201: 20 unit (U), 50 U or 75 U. Based on safety data of Stage 1, Stage 2 was started, and participants received NT 201 20 U or 100 U. After completion of MP, participants had the opportunity to receive an optional follow-up treatment with NT 201 20 U in OLEX period. As planned, 20 U group data from Stages 1 and 2 were pooled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '241', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1 and 2 Pooled: NT 201 20 U', 'description': 'Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'BG001', 'title': 'NT 201 50 U', 'description': 'Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'BG002', 'title': 'NT 201 75 U', 'description': 'Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'BG003', 'title': 'NT 201 100 U', 'description': 'Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '11.43', 'groupId': 'BG000'}, {'value': '46.9', 'spread': '10.27', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '13.75', 'groupId': 'BG002'}, {'value': '49.4', 'spread': '11.19', 'groupId': 'BG003'}, {'value': '49.4', 'spread': '11.81', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '213', 'groupId': 'BG004'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Facial Wrinkle Scale (FWS) severity at maximum frown as assessed by the investigator', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor).", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) was subset of participants exposed to study medication for whom any efficacy variable was available.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-21', 'size': 5905449, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-29T04:24', 'hasProtocol': True}, {'date': '2021-01-14', 'size': 1487306, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-29T04:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2021-09-07', 'completionDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2019-01-15', 'dispFirstSubmitQcDate': '2021-09-07', 'resultsFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2019-01-15', 'dispFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-07', 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS', 'timeFrame': 'From the time of first treatment up to Day 360', 'description': "Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation."}, {'measure': 'Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'From the time of first treatment up to Day 390'}, {'measure': 'Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)', 'timeFrame': 'From the time of first treatment up to Day 390'}, {'measure': 'Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)', 'timeFrame': 'From the time of first treatment up to Day 390'}, {'measure': 'Number of Participants With at Least One Treatment Related TEAE', 'timeFrame': 'From the time of first treatment up to Day 390'}, {'measure': 'Number of Participants With at Least One Treatment Related TESAE', 'timeFrame': 'From the time of first treatment up to Day 390'}], 'secondaryOutcomes': [{'measure': 'Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS', 'timeFrame': 'From the time of first treatment up to Day 360', 'description': "Duration of effect was defined as time between treatment and first point in time when score was moderate or severe again. If no effect was observed, duration of effect was set to 0. Effect was defined by a score of none (0) or mild (1) at maximum frown as assessed by investigator according to FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation."}, {'measure': 'Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS', 'timeFrame': 'From the time of first treatment up to Day 360', 'description': "Duration of effect: time between treatment and first point in time when improvement was less than 2 points again. If no effect was observed, duration of effect was set to 0. Effect: at least a 2-point improvement from baseline at maximum frown as assessed by investigator on the FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation."}, {'measure': "Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS", 'timeFrame': 'At Day 180', 'description': "Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CIs for percentage of participants were based on Pearson-clopper method."}, {'measure': "Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS", 'timeFrame': 'At Day 180', 'description': "Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method."}, {'measure': "Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS", 'timeFrame': 'At Day 180', 'description': "Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method."}, {'measure': "Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS", 'timeFrame': 'At Day 180', 'description': "Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \\[that is, visible furrows\\]), 2 (moderately strong muscle action possible \\[that is, visible muscle bulges\\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Glabellar Frown Lines']}, 'referencesModule': {'references': [{'pmid': '34636520', 'type': 'BACKGROUND', 'citation': 'Kerscher M, Fabi S, Fischer T, Gold M, Joseph J, Prager W, Rzany B, Yoelin S, Roll S, Klein G, Maas C. IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines. J Drugs Dermatol. 2021 Oct 1;20(10):1052-1060. doi: 10.36849/JDD.6377.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).', 'detailedDescription': 'This prospective, randomized, double-blind, multi-Center clinical study consists of a two stage experimental main period comparing different dose groups, followed by an optional open-label extension period (20 Units follow-up treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participant 18 years or over.\n* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).\n* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.\n\nExclusion Criteria:\n\n* Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.\n* Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.\n* Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.\n* Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.\n* Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.\n* Any surgery or scars in the glabellar area.\n* Marked facial asymmetry.\n* Eyelid ptosis.\n* Marked brow ptosis and/or dermatochalasis.\n* Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT03806933', 'briefTitle': 'Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'A Prospective, Randomized, Double-blind, Multicenter Study to Investigate the Safety and Duration of Effect of Different NT 201 Dose Groups Following the Treatment of Glabellar Frown Lines', 'orgStudyIdInfo': {'id': 'M602011015'}, 'secondaryIdInfos': [{'id': '2018-002743-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NT 201 Dose group 1', 'description': 'Stage 1 and 2. Intramuscular injection into the glabellar area.', 'interventionNames': ['Drug: NT 201']}, {'type': 'EXPERIMENTAL', 'label': 'NT 201 Dose group 2', 'description': 'Stage 1. Intramuscular injection into the glabellar area.', 'interventionNames': ['Drug: NT 201']}, {'type': 'EXPERIMENTAL', 'label': 'NT 201 Dose group 3', 'description': 'Stage 1. Intramuscular injection into the glabellar area.', 'interventionNames': ['Drug: NT 201']}, {'type': 'EXPERIMENTAL', 'label': 'NT 201 Dose group 4', 'description': 'Stage 2. Intramuscular injection into the glabellar area.', 'interventionNames': ['Drug: NT 201']}, {'type': 'EXPERIMENTAL', 'label': 'NT 201 Dose group 5', 'description': 'Open Label Extension Period. Intramuscular injection into the glabellar area.', 'interventionNames': ['Drug: NT 201']}], 'interventions': [{'name': 'NT 201', 'type': 'DRUG', 'otherNames': ['IncobotulinumtoxinA', 'Xeomin', 'Botulinum toxin type A (150 kiloDalton), free from complexing proteins'], 'description': 'Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).', 'armGroupLabels': ['NT 201 Dose group 1', 'NT 201 Dose group 2', 'NT 201 Dose group 3', 'NT 201 Dose group 4', 'NT 201 Dose group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Testing of Beverly Hills, Merz Investigational Site #0010395', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Medical Associates Inc., Merz Investigational Site #0010435', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Cosmetic Laser Dermatology, Merz Investigational Site #0010321', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'The Maas Clinics, Merz Investigational Site #0010338', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center, Merz Investigational Site #0010097', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '10707', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22609', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Skin & Laser Center, Merz Investigational Site #0490362', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}], 'overallOfficials': [{'name': 'Merz Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Pharmaceuticals GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Aesthetics GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merz Pharmaceuticals GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}