Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 4:26 PM
Study NCT ID:
NCT02904057
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2016-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@merz.de', 'phone': '+49 69 1503 1', 'title': 'Public Disclosure Manager', 'organization': 'Merz Pharmaceuticals GmbH'}, 'certainAgreement': {'otherDetails': 'Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 4', 'description': 'The investigator asked the participant for adverse events (AEs) systematically at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group: Radiesse (+) Injectable Implant', 'description': 'Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group: Untreated', 'description': 'Participants did not receive jawline treatment.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Jawlines', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Radiesse (+) Injectable Implant', 'description': 'Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).'}, {'id': 'OG001', 'title': 'Control Group: Untreated', 'description': 'Participants did not receive jawline treatment.'}], 'classes': [{'title': 'Imputed data', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Observed data', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.1', 'ciLowerLimit': '73.4', 'ciUpperLimit': '98.8', 'groupDescription': 'Imputed Data: Difference between proportion of treatment responders and control responders (P\\[treatment\\] - P\\[control\\] with confidence interval (CI) was calculated using an exact approach.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.1', 'ciLowerLimit': '73.4', 'ciUpperLimit': '98.8', 'groupDescription': 'Observed Data: Difference between proportion of treatment responders and control responders (P\\[treatment\\] - P\\[control\\] with CI was calculated using an exact approach.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume and score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume.', 'unitOfMeasure': 'percentage of jawlines', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Jawlines', 'denomUnitsSelected': 'Jawlines', 'populationDescription': 'The full analysis set (FAS) comprised of the subset of participants in the randomized set for whom the primary efficacy variable was available.'}, {'type': 'SECONDARY', 'title': 'Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Jawlines', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Radiesse (+) Injectable Implant', 'description': 'Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).'}], 'classes': [{'title': 'GAIS improvement and MJAS ≥ 1-grade improvement', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}]}]}, {'title': 'iGAIS improvement and MJAS no improvement', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'iGAIS no improvement and MJAS ≥ 1-grade improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'iGAIS no improvement and MJAS no improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume, and; score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume. The GAIS is a 7-point scale, where score ranges from (0-7) as: score 0: very much worse; score 1: much worse; score 3: worse; score 4: no change; score 5: improved; score 6: much improved; score 7: very much improved. An "improvement" on the GAIS for the treating investigator was classified as investigators who rated participants as "improved", "much improved", or "very much improved". All other ratings on the GAIS were classified as "no improvement".', 'unitOfMeasure': 'percentage of jawlines', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Jawlines', 'denomUnitsSelected': 'Jawlines', 'populationDescription': 'The FAS comprised the subset of participants in the randomized set for whom the primary efficacy variable was available. The GAIS was assessed only in treated subjects (i.e., not in Control Group: Untreated); therefore, the analysis is on observed cases, where data were available for both assessments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group: Radiesse (+) Injectable Implant', 'description': 'Participants received Radiesse+Lidocaine Injectable Implant up to 3.0 cubic centimeter (cc) volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).'}, {'id': 'FG001', 'title': 'Control Group: Untreated', 'description': 'Participants did not receive jawline treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 2 sites in Canada.', 'preAssignmentDetails': 'A total of 29 participants were screened for the study and all 29 participants were enrolled and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group: Radiesse (+) Injectable Implant', 'description': 'Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).'}, {'id': 'BG001', 'title': 'Control Group: Untreated', 'description': 'Participants did not receive jawline treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '7.01', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '6.39', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '6.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick skin type', 'classes': [{'categories': [{'title': 'Type I', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Type II', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Type III', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Type IV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Type V', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Type VI', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Fitzpatrick skin type depends on the amount of melanin pigment in the skin. This is determined by constitutional colour (white, brown or black skin) and the result of exposure to ultraviolet radiation (tanning). It depends on type of skin where, skin type I:pale or white skin-always burns, does not tan;skin type II:fair skin-burns easily, tans poorly;skin type III:darker white skin-tans after initial burn;skin type IV:light brown skin-burns minimally, tans easily;skin type V:brown skin-rarely burns, tans darkly easily and skin type VI:dark brown or black skin-never burns, always tans darkly.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The randomized set comprised of participants enrolled and randomized into the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2017-06-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2016-09-13', 'dispFirstSubmitQcDate': '2017-06-07', 'resultsFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2016-09-13', 'dispFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-16', 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4', 'timeFrame': 'Week 4', 'description': 'MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume and score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume.'}], 'secondaryOutcomes': [{'measure': 'Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4', 'timeFrame': 'Week 4', 'description': 'MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume, and; score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume. The GAIS is a 7-point scale, where score ranges from (0-7) as: score 0: very much worse; score 1: much worse; score 3: worse; score 4: no change; score 5: improved; score 6: much improved; score 7: very much improved. An "improvement" on the GAIS for the treating investigator was classified as investigators who rated participants as "improved", "much improved", or "very much improved". All other ratings on the GAIS were classified as "no improvement".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Volume Loss of the Jawline']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument', 'detailedDescription': 'A prospective, open label study, in which both right and left jawlines will receive treatment with Radiesse (+). Subjects will be randomized in a 2:1 ratio to either a treatment group or an untreated control group. Jawlines will be assessed by masked evaluators on the MJGS. Treating physicians and treatment group subjects will assess satisfaction on the GAIS. Treatment group subjects will self-report aesthetic outcomes on the FACE-Q instrument.\n\nTreatment subjects will be evaluated at enrollment, and 1, 2 and 4 weeks after enrollment. Control group subjects will be required to be evaluated at enrollment and 4 weeks after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.\n2. Is at least 18 years of age.\n3. Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.\n4. Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.\n\nExclusion Criteria:\n\n1. Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.\n2. Has had surgery on the jawbone or has surgical permanent implant to the face or neck.\n3. Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.\n4. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.\n5. Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.'}, 'identificationModule': {'nctId': 'NCT02904057', 'briefTitle': 'Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Evaluation of the Merz Jawline Grading Scale (MJGS) Following Radiesse (+)® Correction of Subcutaneous Volume Loss and Contour Deficits of the Jawline - a Canadian Pilot Study', 'orgStudyIdInfo': {'id': 'P140891'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'The treatment group will receive Radiesse (+) injectable implant up to 3.0 cc per jawline.', 'interventionNames': ['Device: Radiesse (+) Injectable Implant']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group is not treated. They will undergo assessments such as photographs, jaw grading and jaw function tests.'}], 'interventions': [{'name': 'Radiesse (+) Injectable Implant', 'type': 'DEVICE', 'description': 'Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Kuligowski, MD,PHD,MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}