Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-21 @ 12:17 PM
Study NCT ID:
NCT02677805
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.studies@croma.at', 'phone': '+432262684680', 'title': 'Clinical Development - Head of Clinical Operations', 'organization': 'Croma Pharma GmbH'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 weeks post first treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 12, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 2, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Botulinum Toxin A Open Label Extension Arm', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.\n\n20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 18, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators' and the Subjects' In-clinic Assessments", 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': "The primary endpoint is the percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale (FWS) at baseline or week 4 were assigned as being non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders at Maximum Frown at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 12 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale (FWS) at baseline or week 12 were assigned as being non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders at Maximum Frown at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.121', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 16 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for week 16 or who were re-treated before week 16. They were analyzed as randomized and participants who were re-treated before week 16 were counted as non-responders.'}, {'type': 'SECONDARY', 'title': "The Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest at Week 4 Based Separately on the Investigators' and the Subjects' In-clinic Assessments", 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}], 'classes': [{'title': "Investigator's In-clinic Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': "Subject's In-clinic Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': "Test performed for Investigator's In-clinic Assessment", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': "Test performed for Subject's In-clinic Assessment", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': "The Percentage of subjects with a ≥ 1 point reduction in Facial Wrinkle Scale (FWS) score at rest at week 4 in the first treatment cycle, based separately on the investigators' and the subjects' in-clinic assessments (applicable only for subjects who have a FWS score at rest ≥ 1 at baseline). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and who had a Facial Wrinkle Scale (FWS) score at rest ≥1 at baseline. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale at week 4 were assigned as being non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders at Maximum Frown at Weeks 20, 24, 28 and 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}], 'classes': [{'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': 'Test performed for responders rates at week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 20, Week 24, Week 28, Week 32', 'description': "Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at the respective visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for the respective visit. They were analyzed as randomized. In addition, only for Week 20 visit participants who were re-treated before week 20 were counted as non-responders in the analysis.'}, {'type': 'SECONDARY', 'title': 'Extent of Change in Psychological Impact (Emotional and Social Functioning and Concerns Relating to Glabellar Lines)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}], 'classes': [{'title': 'Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-40.59', 'spread': '30.511', 'groupId': 'OG000'}, {'value': '-4.22', 'spread': '20.426', 'groupId': 'OG001'}]}]}, {'title': 'Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-33.50', 'spread': '33.100', 'groupId': 'OG000'}, {'value': '-10.38', 'spread': '20.596', 'groupId': 'OG001'}]}]}, {'title': 'Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-37.55', 'spread': '29.414', 'groupId': 'OG000'}, {'value': '-6.84', 'spread': '18.238', 'groupId': 'OG001'}]}]}, {'title': 'FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '41.56', 'spread': '26.649', 'groupId': 'OG000'}, {'value': '4.84', 'spread': '17.932', 'groupId': 'OG001'}]}]}, {'title': 'Age Appraisal VAS - Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-2.49', 'spread': '3.997', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '4.158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': 'Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': 'Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': 'Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': 'Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.', 'groupDescription': 'Test performed for FACE-Q Age Appraisal VAS score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Extent of change in psychological impact at week 4 after first treatment, relative to baseline, assessed by\n\n* modified Skindex-16 (Glabellar Line Quality of Life Scale, \\[GL-QoL\\]): Each of 7 items rated on 5-point scale: 0/Never, 1/Rarely, 2/Sometimes, 3/Often, 4/Always bothered, than rescaled to a 0 to 100 standardized score; Emotional Domain is the mean of 4 of the items; Social Functioning Domain is the mean of 3 of the items; Overall score is the mean of all 7 items. All reported scores ranging from 0 (best outcome) to 100 (worst outcome).\n* validated FACE-Q Appraisal of Lines Between Eyebrows scale: Each of 7 items rated on 4-point scale: 1/Not at all, 2/a little, 3/moderately, 4/extremely. Reported score is the sum of the 7 items, standardized on a scale from 0 (worst outcome) to 100 (best outcome).\n* Age Appraisal visual analog scale \\[VAS\\]: Perception of Age compared to actual age, in years ranging from -15 years (best outcome) to +15 years (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for the respective timepoint. They were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders at Maximum Frown at Weeks 1, 2 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1, Week 2, Week 8', 'description': "The Percentage of responders among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score at maximum frown of 0 or 1 and an improvement ≥ 2 points in FWS score (at maximum frown) during the first treatment cycle visit relative to baseline, based on both the investigators' and the subjects' in-clinic assessments (composite endpoint, at weeks 1, 2 and 8). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale (FWS) at baseline or at the respective visit were assigned as being non-responders.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects With ≥ 2-point Reduction in Facial Wrinkle Scale (FWS) Score (at Maximum Frown) Based on Independent Raters' Assessment of of Photographs", 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2, Week 4, Week 12, Week 16, Week 20', 'description': "The percentage of subjects with ≥ 2-point reduction in Facial Wrinkle Scale (FWS) score (at maximum frown) in the BoNT/A-DP and placebo groups during the first treatment cycle visit relative to baseline, based on the independent raters' assessment of photographs (at baseline and visits 2, 4, 12, 16 and 20 weeks after treatment, within the first treatment cycle). The median value of all assessments of the same photography was considered for analysis. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for the respective timepoint. Participants were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Effect in the BoNT/A-DP and Placebo Groups in the First Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '9.0'}, {'value': 'NA', 'comment': 'The median and inter-quartile range cannot be calculated due to the low number of subjects showing an effect in this arm.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment at Day 0 to Week 4 in Treatment Cycle 1', 'description': 'Time to onset of effect in the BoNT/A-DP and placebo groups in the first treatment cycle, as measured at weeks 1, 2 and 4 based separately on subject and investigator assessment. Onset of effect defined as at least a 1 point improvement in Facial Wrinkle Scale (FWS) score from baseline (at maximum frown). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for the respective timepoint. Participants were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment, During Each Treatment Cycle, as Assessed by the Validated FACE-Q Satisfaction With Outcome Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.\n\n20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles'}], 'classes': [{'title': 'Cycle 1 Week 4 - pleased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Week 4 - expected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Week 4 - great', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Week 4 - look in mirror', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Week 4 - fantastic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Week 4 - miraculous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Week 4 - pleased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '14', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '16', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '50', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '113', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Week 4 - expected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '19', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '21', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '62', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '91', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Week 4 - great', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '21', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '27', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '50', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '95', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Week 4 - look in mirror', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '17', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '39', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '65', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '72', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Week 4 - fantastic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '28', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '29', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '49', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '87', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Week 4 - miraculous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '38', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '32', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '65', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '58', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Week 4 - pleased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '14', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '14', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '37', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '106', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Week 4 - expected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '18', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '20', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '41', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '92', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Week 4 - great', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '16', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '27', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '32', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '96', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Week 4 - look in mirror', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '16', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '32', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '56', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '67', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Week 4 - fantastic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '24', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '32', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '41', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '74', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Week 4 - miraculous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '40', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '31', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '45', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '55', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 Week 4 - pleased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '15', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '9', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '41', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '84', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 Week 4 - expected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '19', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '20', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '34', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '76', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 Week 4 - great', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '20', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '27', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '27', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '75', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 Week 4 - look in mirror', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '18', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '33', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '41', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '57', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 Week 4 - fantastic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '29', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '26', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '33', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '61', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 Week 4 - miraculous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Definitely disagree', 'measurements': [{'value': '42', 'groupId': 'OG002'}]}, {'title': 'Somewhat disagree', 'measurements': [{'value': '27', 'groupId': 'OG002'}]}, {'title': 'Somewhat agree', 'measurements': [{'value': '36', 'groupId': 'OG002'}]}, {'title': 'Definitely agree', 'measurements': [{'value': '44', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4 of Treatment Cycles 1, 2, 3 and 4', 'description': 'The extent of subject perceptions of effect of, and satisfaction with, treatment in the BoNT/A-DP and placebo groups, during each treatment cycle, as assessed by the validated FACE-Q Satisfaction with Outcome Scale. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient\'s satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree", "somewhat agree", "somewhat disagree", and "definitely disagree".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication in the respective treatment cycle. Participants were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest Based on the Independent Rater's Assessment of Photographs", 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2, Week 4, Week 12, Week 16, Week 20, Week 24, Week 28', 'description': "The Percentage of subjects with a ≥ 1 point reduction in Facial Wrinkle Scale (FWS) score at rest in the BoNT/A-DP and placebo groups, relative to baseline, during the first treatment cycle, based on the independent raters' assessment of photographs. The median value of all assessments of the same photography was considered for analysis. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for the respective timepoint. Participants were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at 4 Weeks After Re-treatment Relative to the Rating at the Preceding End-of-Cycle Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Open Label Extension Arm', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.\n\n20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles'}], 'classes': [{'title': 'Week 4 after 1st Re-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 after 2nd Re-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 after 3rd Re-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4 of Treatment Cycles 2, 3 and 4', 'description': "The percentage of subjects with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at 4 weeks after re-treatment relative to the rating at the preceding end-of-cycle visit, based on both the investigators' and the subjects' in-clinic assessments (composite endpoint). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all randomized subjects who received at least one injection with study medication in the respective treatment cycle and for whom data are available for the respective timepoint. Participants were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.\n\n20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles'}], 'classes': [{'title': 'Subjects with any Treatment Emergent Adverse Event (TEAE)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Study Medication Related TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Injection Procedure Related TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Severe TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Adverse Events of Special Interest (AESI)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion (60 weeks)', 'description': 'Frequency, severity and causal relationship of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the entire study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Anti-Drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.\n\n20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion (60 weeks)', 'description': 'Number of Participants with Neutralizing Anti-Drug Antibodies Antibody formation, evaluation pre-dose before each treatment, at 4 weeks after each treatment and at the final study visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication. Participants were analyzed as treated. Confirmation assays have only been performed for subjects with a reactive Screening Assay result.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Alanine Aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '7.939', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '19.151', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '9.132', 'groupId': 'OG002'}, {'value': '0.28', 'spread': '11.333', 'groupId': 'OG003'}, {'value': '0.93', 'spread': '8.528', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Alkaline Phosphatase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '8.174', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '8.989', 'groupId': 'OG001'}, {'value': '1.18', 'spread': '7.898', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '9.704', 'groupId': 'OG003'}, {'value': '-0.53', 'spread': '8.414', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Aspartate Aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '11.156', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '11.206', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '10.539', 'groupId': 'OG002'}, {'value': '-0.85', 'spread': '12.249', 'groupId': 'OG003'}, {'value': '0.56', 'spread': '8.055', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Gamma Glutamyl Transferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '7.418', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '16.315', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '8.245', 'groupId': 'OG002'}, {'value': '2.15', 'spread': '16.974', 'groupId': 'OG003'}, {'value': '-0.48', 'spread': '8.998', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase as per the study schedule', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Bilirubin, Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Bilirubin (μmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '3.233', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '3.588', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '2.949', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '3.494', 'groupId': 'OG003'}, {'value': '0.10', 'spread': '3.580', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Creatinine (μmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '8.514', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '6.487', 'groupId': 'OG001'}, {'value': '-0.56', 'spread': '8.240', 'groupId': 'OG002'}, {'value': '-1.07', 'spread': '7.315', 'groupId': 'OG003'}, {'value': '-1.68', 'spread': '8.284', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Bilirubin, Creatinine as per the study schedule as change from baseline', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Cholesterol, Glucose, Potassium, Sodium, Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Cholesterol (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.559', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.473', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.533', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.594', 'groupId': 'OG003'}, {'value': '0.01', 'spread': '0.615', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Glucose (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '1.014', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.411', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '1.339', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '1.133', 'groupId': 'OG003'}, {'value': '0.12', 'spread': '1.202', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Potassium (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.393', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.357', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.376', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.395', 'groupId': 'OG003'}, {'value': '-0.03', 'spread': '0.365', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Sodium (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '2.101', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '2.046', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '1.939', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '2.021', 'groupId': 'OG003'}, {'value': '0.26', 'spread': '1.959', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Urea Nitrogen (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '1.278', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.327', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '1.280', 'groupId': 'OG002'}, {'value': '-0.13', 'spread': '1.410', 'groupId': 'OG003'}, {'value': '-0.35', 'spread': '1.471', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Cholesterol, Glucose, Potassium, Sodium, Urea Nitrogen as per the study schedule', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Basophils (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.031', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.043', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '0.035', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Eosinophils (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.056', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.060', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.084', 'groupId': 'OG003'}, {'value': '0.01', 'spread': '0.109', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Leukocytes (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.252', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '1.622', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '1.303', 'groupId': 'OG002'}, {'value': '0.23', 'spread': '1.418', 'groupId': 'OG003'}, {'value': '-0.06', 'spread': '1.454', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Lymphocytes (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.369', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.429', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.360', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.432', 'groupId': 'OG003'}, {'value': '-0.02', 'spread': '0.428', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Monocytes (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.147', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.156', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.127', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '0.149', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Neutrophils (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.152', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '1.483', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '1.221', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '1.290', 'groupId': 'OG003'}, {'value': '-0.05', 'spread': '1.290', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Platelets (x10^9 cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.85', 'spread': '28.665', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '30.057', 'groupId': 'OG001'}, {'value': '5.28', 'spread': '30.961', 'groupId': 'OG002'}, {'value': '12.08', 'spread': '32.635', 'groupId': 'OG003'}, {'value': '4.70', 'spread': '32.814', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets as per the study schedule', 'unitOfMeasure': 'x10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.246', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.203', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.214', 'groupId': 'OG003'}, {'value': '-0.03', 'spread': '0.201', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Erythrocytes as per the study schedule', 'unitOfMeasure': 'x10^12 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Erythrocyte MCHC, Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Erythrocyte MCHC(g/dL)', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '1.061', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.344', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '1.178', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '1.416', 'groupId': 'OG003'}, {'value': '-0.62', 'spread': '1.457', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Hemoglobin (g/dL)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.678', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.736', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.626', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.718', 'groupId': 'OG003'}, {'value': '-0.20', 'spread': '0.656', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Erythrocyte MCHC, Hemoglobin as per the study schedule', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of of Erythrocyte MCV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '2.633', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '4.121', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '3.408', 'groupId': 'OG002'}, {'value': '-1.03', 'spread': '4.307', 'groupId': 'OG003'}, {'value': '1.14', 'spread': '4.747', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Erythrocyte MCV as per the study schedule', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '137', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Basophils/Leukocytes (%)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.472', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.642', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.570', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.636', 'groupId': 'OG003'}, {'value': '0.03', 'spread': '0.568', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Eosinophils/Leukocytes (%)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '1.294', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.892', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '1.107', 'groupId': 'OG002'}, {'value': '0.45', 'spread': '1.394', 'groupId': 'OG003'}, {'value': '0.13', 'spread': '1.336', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Lymphocytes/Leukocytes (%)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '6.185', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '6.856', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '6.272', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '6.927', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '6.700', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Monocytes/Leukocytes (%)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '2.203', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.923', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '2.312', 'groupId': 'OG002'}, {'value': '-0.40', 'spread': '1.927', 'groupId': 'OG003'}, {'value': '0.02', 'spread': '2.308', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Neutrophils/Leukocytes (%)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '7.095', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '8.037', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '7.605', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '8.039', 'groupId': 'OG003'}, {'value': '-0.15', 'spread': '7.600', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes as per the study schedule as change from baseline', 'unitOfMeasure': '% of leukocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'title': 'Week 4 of each treatment cycle - Systolic Blood Pressure (mmHg)', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '13.027', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '9.897', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '13.150', 'groupId': 'OG002'}, {'value': '-0.06', 'spread': '14.910', 'groupId': 'OG003'}, {'value': '-0.24', 'spread': '13.729', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 of each treatment cycle - Diastolic Blood Pressure (mmHg)', 'categories': [{'measurements': [{'value': '-2.48', 'spread': '10.165', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '9.458', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '8.698', 'groupId': 'OG002'}, {'value': '3.08', 'spread': '9.374', 'groupId': 'OG003'}, {'value': '3.96', 'spread': '9.343', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of Treatment Cycles 1, 2, 3 and 4', 'description': 'Safety assessments by evaluating change from baseline of Systolic and Diastolic Blood Pressure as per the study schedule', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area'}, {'id': 'OG002', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 2.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 2'}, {'id': 'OG003', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 3', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 3.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 3'}, {'id': 'OG004', 'title': 'Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 4', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 additional treatment cycles. This arm is designated for Study Treatment Cycle 4.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in Treatment Cycle 4'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.48', 'spread': '10.165', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '9.458', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '8.698', 'groupId': 'OG002'}, {'value': '3.08', 'spread': '9.374', 'groupId': 'OG003'}, {'value': '3.96', 'spread': '9.343', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 of Treatment Cycles 1, 2, 3 and 4', 'description': 'Safety assessments by evaluating change from baseline of Pulse rate as per the study schedule', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Normal and Abnormal Electrocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A - Normal Baseline Electrocardiogram Interpretation', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area Subjects had an electrocardiogram interpretation of normal at baseline.'}, {'id': 'OG001', 'title': 'Botulinum Toxin A - Abnormal Baseline Electrocardiogram Interpretation', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area Subjects had an electrocardiogram interpretation of abnormal at baseline.'}, {'id': 'OG002', 'title': 'Placebo - Normal Baseline Electrocardiogram Interpretation', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area Subjects had an electrocardiogram interpretation of normal at baseline.'}, {'id': 'OG003', 'title': 'Placebo - Abnormal Baseline Electrocardiogram Interpretation', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area Subjects had an electrocardiogram interpretation of abnormal at baseline.'}], 'classes': [{'categories': [{'title': 'Last observation in Cycle 1 - Normal', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Last observation in Cycle 1 - Abnormal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Last visit of Treatment Cycle 1 (End of Cycle procedures) conducted upon confirmation of eligibility for retreatment, which was assessed starting 12 weeks post-treatment with 4-weekly evaluations up to a maximum of 48 weeks post treatment.', 'description': 'Safety assessments by evaluating Electrocardiogram as per the study schedule', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population used consists of all subjects who received at least one injection with study medication and who have data available post-baseline and the respective category of baseline electrocardiogram interpretation. Participants were analyzed as treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}, {'id': 'FG002', 'title': 'Botulinum Toxin A Open Label Extension Arm', 'description': 'Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.\n\n20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles'}], 'periods': [{'title': 'Double Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '195'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Of 251 enrolled participants, 213 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin A', 'description': 'Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.\n\nBotulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.\n\nPlacebo: Injection, sodium chloride 0.9 % divided in five 0.1 mL i.m. injections into glabellar area'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.04', 'spread': '10.458', 'groupId': 'BG000'}, {'value': '52.43', 'spread': '10.137', 'groupId': 'BG001'}, {'value': '52.14', 'spread': '10.357', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Facial Wrinkle Scale at Maximum Frown by Investigator and Subject In-clinic Assessment', 'classes': [{'title': "Investigator's In-clinic Assessment", 'categories': [{'title': 'No facial wrinkles', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Mild facial wrinkles', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Moderate facial wrinkles', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Severe facial wrinkles', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}, {'title': "Subject's In-clinic Assessment", 'categories': [{'title': 'No facial wrinkles', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Mild facial wrinkles', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Moderate facial wrinkles', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Severe facial wrinkles', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Facial Wrinkle Scale scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-25', 'size': 7440813, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-11T07:32', 'hasProtocol': True}, {'date': '2017-08-15', 'size': 8230484, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-11T07:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'dispFirstSubmitDate': '2020-01-29', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2016-02-04', 'dispFirstSubmitQcDate': '2020-01-29', 'resultsFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2016-02-04', 'dispFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-11', 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators' and the Subjects' In-clinic Assessments", 'timeFrame': 'Week 4', 'description': "The primary endpoint is the percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders at Maximum Frown at Week 12', 'timeFrame': 'Week 12', 'description': "Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 12 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': 'Percentage of Responders at Maximum Frown at Week 16', 'timeFrame': 'Week 16', 'description': "Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 16 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': "The Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest at Week 4 Based Separately on the Investigators' and the Subjects' In-clinic Assessments", 'timeFrame': 'Week 4', 'description': "The Percentage of subjects with a ≥ 1 point reduction in Facial Wrinkle Scale (FWS) score at rest at week 4 in the first treatment cycle, based separately on the investigators' and the subjects' in-clinic assessments (applicable only for subjects who have a FWS score at rest ≥ 1 at baseline). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': 'Percentage of Responders at Maximum Frown at Weeks 20, 24, 28 and 32', 'timeFrame': 'Week 20, Week 24, Week 28, Week 32', 'description': "Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at the respective visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': 'Extent of Change in Psychological Impact (Emotional and Social Functioning and Concerns Relating to Glabellar Lines)', 'timeFrame': 'Week 4', 'description': 'Extent of change in psychological impact at week 4 after first treatment, relative to baseline, assessed by\n\n* modified Skindex-16 (Glabellar Line Quality of Life Scale, \\[GL-QoL\\]): Each of 7 items rated on 5-point scale: 0/Never, 1/Rarely, 2/Sometimes, 3/Often, 4/Always bothered, than rescaled to a 0 to 100 standardized score; Emotional Domain is the mean of 4 of the items; Social Functioning Domain is the mean of 3 of the items; Overall score is the mean of all 7 items. All reported scores ranging from 0 (best outcome) to 100 (worst outcome).\n* validated FACE-Q Appraisal of Lines Between Eyebrows scale: Each of 7 items rated on 4-point scale: 1/Not at all, 2/a little, 3/moderately, 4/extremely. Reported score is the sum of the 7 items, standardized on a scale from 0 (worst outcome) to 100 (best outcome).\n* Age Appraisal visual analog scale \\[VAS\\]: Perception of Age compared to actual age, in years ranging from -15 years (best outcome) to +15 years (worst outcome).'}, {'measure': 'Percentage of Responders at Maximum Frown at Weeks 1, 2 and 8', 'timeFrame': 'Week 1, Week 2, Week 8', 'description': "The Percentage of responders among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score at maximum frown of 0 or 1 and an improvement ≥ 2 points in FWS score (at maximum frown) during the first treatment cycle visit relative to baseline, based on both the investigators' and the subjects' in-clinic assessments (composite endpoint, at weeks 1, 2 and 8). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': "Percentage of Subjects With ≥ 2-point Reduction in Facial Wrinkle Scale (FWS) Score (at Maximum Frown) Based on Independent Raters' Assessment of of Photographs", 'timeFrame': 'Week 2, Week 4, Week 12, Week 16, Week 20', 'description': "The percentage of subjects with ≥ 2-point reduction in Facial Wrinkle Scale (FWS) score (at maximum frown) in the BoNT/A-DP and placebo groups during the first treatment cycle visit relative to baseline, based on the independent raters' assessment of photographs (at baseline and visits 2, 4, 12, 16 and 20 weeks after treatment, within the first treatment cycle). The median value of all assessments of the same photography was considered for analysis. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': 'Time to Onset of Effect in the BoNT/A-DP and Placebo Groups in the First Treatment Cycle', 'timeFrame': 'From treatment at Day 0 to Week 4 in Treatment Cycle 1', 'description': 'Time to onset of effect in the BoNT/A-DP and placebo groups in the first treatment cycle, as measured at weeks 1, 2 and 4 based separately on subject and investigator assessment. Onset of effect defined as at least a 1 point improvement in Facial Wrinkle Scale (FWS) score from baseline (at maximum frown). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.'}, {'measure': 'Satisfaction With Treatment, During Each Treatment Cycle, as Assessed by the Validated FACE-Q Satisfaction With Outcome Scale', 'timeFrame': 'Week 4 of Treatment Cycles 1, 2, 3 and 4', 'description': 'The extent of subject perceptions of effect of, and satisfaction with, treatment in the BoNT/A-DP and placebo groups, during each treatment cycle, as assessed by the validated FACE-Q Satisfaction with Outcome Scale. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient\'s satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree", "somewhat agree", "somewhat disagree", and "definitely disagree".'}, {'measure': "Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest Based on the Independent Rater's Assessment of Photographs", 'timeFrame': 'Week 2, Week 4, Week 12, Week 16, Week 20, Week 24, Week 28', 'description': "The Percentage of subjects with a ≥ 1 point reduction in Facial Wrinkle Scale (FWS) score at rest in the BoNT/A-DP and placebo groups, relative to baseline, during the first treatment cycle, based on the independent raters' assessment of photographs. The median value of all assessments of the same photography was considered for analysis. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': 'Percentage of Subjects With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at 4 Weeks After Re-treatment Relative to the Rating at the Preceding End-of-Cycle Visit', 'timeFrame': 'Week 4 of Treatment Cycles 2, 3 and 4', 'description': "The percentage of subjects with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at 4 weeks after re-treatment relative to the rating at the preceding end-of-cycle visit, based on both the investigators' and the subjects' in-clinic assessments (composite endpoint). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles."}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)', 'timeFrame': 'Through study completion (60 weeks)', 'description': 'Frequency, severity and causal relationship of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the entire study period.'}, {'measure': 'Number of Participants With Neutralizing Anti-Drug Antibodies', 'timeFrame': 'Through study completion (60 weeks)', 'description': 'Number of Participants with Neutralizing Anti-Drug Antibodies Antibody formation, evaluation pre-dose before each treatment, at 4 weeks after each treatment and at the final study visit.'}, {'measure': 'Change From Baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase as per the study schedule'}, {'measure': 'Change From Baseline of Bilirubin, Creatinine', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Bilirubin, Creatinine as per the study schedule as change from baseline'}, {'measure': 'Change From Baseline of Cholesterol, Glucose, Potassium, Sodium, Urea Nitrogen', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Cholesterol, Glucose, Potassium, Sodium, Urea Nitrogen as per the study schedule'}, {'measure': 'Change From Baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets as per the study schedule'}, {'measure': 'Change From Baseline of Erythrocytes', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Erythrocytes as per the study schedule'}, {'measure': 'Change From Baseline of Erythrocyte MCHC, Hemoglobin', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Erythrocyte MCHC, Hemoglobin as per the study schedule'}, {'measure': 'Change From Baseline of of Erythrocyte MCV', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Erythrocyte MCV as per the study schedule'}, {'measure': 'Change From Baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes', 'timeFrame': 'Week 4 of each treatment cycle', 'description': 'Safety assessments by evaluating change from baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes as per the study schedule as change from baseline'}, {'measure': 'Change From Baseline of Systolic and Diastolic Blood Pressure', 'timeFrame': 'Week 4 of Treatment Cycles 1, 2, 3 and 4', 'description': 'Safety assessments by evaluating change from baseline of Systolic and Diastolic Blood Pressure as per the study schedule'}, {'measure': 'Change From Baseline of Pulse Rate', 'timeFrame': 'Week 4 of Treatment Cycles 1, 2, 3 and 4', 'description': 'Safety assessments by evaluating change from baseline of Pulse rate as per the study schedule'}, {'measure': 'Number of Participants With Normal and Abnormal Electrocardiogram', 'timeFrame': 'Last visit of Treatment Cycle 1 (End of Cycle procedures) conducted upon confirmation of eligibility for retreatment, which was assessed starting 12 weeks post-treatment with 4-weekly evaluations up to a maximum of 48 weeks post treatment.', 'description': 'Safety assessments by evaluating Electrocardiogram as per the study schedule'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glabellar Frown Lines']}, 'referencesModule': {'references': [{'pmid': '38470985', 'type': 'DERIVED', 'citation': 'Cox SE, Kaufman-Janette J, Cohen JL, Gold M, Joseph J, Nestor MS, Rzany B, Taylor S, Zhou J, Cecerle M, Pueraro E, Irvine R, Dayan S. LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials. Dermatol Surg. 2024 Jun 1;50(6):535-541. doi: 10.1097/DSS.0000000000004152. Epub 2024 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.', 'detailedDescription': 'This multicenter Phase 3 study is comprised of two parts. The first part of the study is a randomized, double blind, placebo-controlled, phase which aims to demonstrate efficacy and safety of BoNT/A-DP compared with placebo. The second part is an open label extension phase to evaluate efficacy after repeat treatments and long term safety. Subjects can receive a maximum of four treatment cycles over the duration of the study, a single treatment in the first cycle compared with placebo, and up to three subsequent treatments in the open label extension study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged ≥ 18 years or older at time of screening on FWS) as determined by in-clinic assessments by both the investigator and the subject(where: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe').\n* Subject has a stable medical condition with no uncontrolled systemic disease.\n* Female subjects of childbearing potential must test negative for pregnancy and agree to use effective birth control during the course of the study.\n* Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the FWS), without glasses obstructing the forehead area.\n* The moderate to severe glabellar lines have an important psychological impact on the subject, as indicated by scores \\>0 on either the Emotional or the Social Functioning subscale of the modified Skindex-16 (GL-QoL).\n\nExclusion Criteria:\n\n* Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to screening, or any planned treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment).\n* Known hypersensitivity to the study medication or its excipients.\n* Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.\n* Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the 3 months prior to screening or planned during the study.\n* Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers,) within 12 months prior to screening or planned during the study.\n* Previous insertion of permanent material in the glabellar area or planned during the study.\n* Any surgery, or history of surgery, in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these, or scars in the glabellar area, or such surgery planned during the study.\n* Active skin disease/infection or irritation at the treatment area.\n* Inability to substantially lessen glabellar frown lines even by physically spreading them apart.\n* Use of a muscle relaxant, , within 2 weeks prior to screening or planned during the study.\n* Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.\n* Pregnant, breastfeeding or planning to become pregnant during the trial.\n* Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to screening or planned during the study.\n* Planned surgery with general anaesthetic (use of local anaesthetic outside the glabellar area is permitted).\n* Participation in another clinical study within one month of screening and throughout the trial.\n* Previous participation in another botulinum toxin aesthetic study which involved the treatment of glabellar lines in combination with canthal lines and/or forehead lines in the previous 18 months.\n* Chronic drug or alcohol abuse (as per investigator discretion).\n\nEligibility Criteria for re-treatment: The following criteria MUST be met for re-treatment:\n\n* At time of re-treatment subject does not have relevant changes to their health status from enrollment, which would have prevented subject's entry into the study according to the inclusion and exclusion criteria\n* The subject must have been randomized to receive treatment and must have received at least one treatment (BoNT/A-DP or placebo).\n* A minimum of 12 weeks must have elapsed since the previous study treatment.\n* The subject's glabellar lines at maximum frown must have relapsed to a FWS score of 2 or 3 as determined by the investigator and the subject.\n* No relevant infection or inflammation in the planned injection area.\n* Negative urine pregnancy test, in women of child-bearing potential.\n* The subject must have received fewer than four study treatments.\n* The subject must agree and consent to re-treatment.\n* Re-treatment will be performed at the latest by week 48."}, 'identificationModule': {'nctId': 'NCT02677805', 'acronym': 'BLESS-II', 'briefTitle': 'Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Croma-Pharma GmbH'}, 'officialTitle': 'Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo Followed by an Open Label Extension Study', 'orgStudyIdInfo': {'id': 'CPH-302-201030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin A', 'description': 'Botulinum Toxin A will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into glabellar area.', 'interventionNames': ['Drug: Botulinum Toxin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be administered in double blind fashion in cycle 1 divided in five 0.1 mL injections into the glabellar area.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin A open label extension phase', 'description': 'Open Label Extension Phase for all Subjects of Arm 1 and 2 for up to 3 treatment cycles', 'interventionNames': ['Drug: Botulinum Toxin A - Open Label']}], 'interventions': [{'name': 'Botulinum Toxin A', 'type': 'DRUG', 'otherNames': ['BoNT/A-DP'], 'description': 'Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area', 'armGroupLabels': ['Botulinum toxin A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sodium chloride 0.9 %'], 'description': 'injection, sodium chloride 0.9% divided in five 0.1 mL i.m. injections into the glabellar area', 'armGroupLabels': ['Placebo']}, {'name': 'Botulinum Toxin A - Open Label', 'type': 'DRUG', 'otherNames': ['BoNT/A-DP'], 'description': 'Open Label Extension Phase with Experimental Drug; Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area', 'armGroupLabels': ['Botulinum toxin A open label extension phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'California Dermatology & Clinical Research Institute', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Clinical and Cosmetic Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Holcomb Kreithen Plastic Surgery', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Hillsborough', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Skin Laser And Surgery Specialists Of New York & New Jersey', 'geoPoint': {'lat': 40.4776, 'lon': -74.62682}}, {'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Dermatology, Cosmetic & Laser Surger', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lorenc Aesthetic Plastic Surgery Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Skintastic Medical', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Croma-Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}