Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-25 @ 9:41 PM
Study NCT ID:
NCT03693404
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Sponsor:
Organization:
Raw JSON
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{'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'philipp.leucht@nyulangone.org', 'phone': '646-501-0291', 'title': 'Philipp Leucht, MD', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'regular investigator assessment / questionnaire', 'eventGroups': [{'id': 'EG000', 'title': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site\n\nGeneral Anesthetics: Placebo group will only receive standard of care general anesthesia', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nMarcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nBupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site\n\nGeneral Anesthetics: Placebo group will only receive standard of care general anesthesia'}, {'id': 'OG001', 'title': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nMarcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nBupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '10', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Operative Day 0', 'description': 'Number of mgs taken of oral morphine', 'unitOfMeasure': 'morphine milligram equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ambulation Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site\n\nGeneral Anesthetics: Placebo group will only receive standard of care general anesthesia'}, {'id': 'OG001', 'title': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nMarcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nBupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '8', 'groupId': 'OG000'}, {'value': '88.9', 'spread': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative Day 3', 'description': 'Ambulation is the ability to walk without the need for any kind of assistance. It is most often used when describing the goals of a patient after a surgery or physical therapy.', 'unitOfMeasure': 'Feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Score on Visual Analogue Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site\n\nGeneral Anesthetics: Placebo group will only receive standard of care general anesthesia'}, {'id': 'OG001', 'title': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nMarcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nBupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 24', 'description': 'VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site\n\nGeneral Anesthetics: Placebo group will only receive standard of care general anesthesia'}, {'id': 'FG001', 'title': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nMarcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nBupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Excluded from Analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site\n\nGeneral Anesthetics: Placebo group will only receive standard of care general anesthesia'}, {'id': 'BG001', 'title': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nMarcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.\n\nBupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '77.5', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '76.5', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-21', 'size': 1302785, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-05T21:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2018-10-01', 'resultsFirstSubmitDate': '2022-06-05', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-28', 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used', 'timeFrame': 'Post-Operative Day 0', 'description': 'Number of mgs taken of oral morphine'}, {'measure': 'Ambulation Distance', 'timeFrame': 'Post-operative Day 3', 'description': 'Ambulation is the ability to walk without the need for any kind of assistance. It is most often used when describing the goals of a patient after a surgery or physical therapy.'}, {'measure': 'Score on Visual Analogue Scale (VAS) for Pain', 'timeFrame': 'Hour 24', 'description': 'VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pertrochanteric Fracture']}, 'referencesModule': {'references': [{'pmid': '37199438', 'type': 'DERIVED', 'citation': 'Ihejirika-Lomedico R, Solasz S, Lorentz N, Egol KA, Leucht P; and NYU Hip Fracture Research Group. Effects of Intraoperative Local Pain Cocktail Injections on Early Function and Patient-Reported Outcomes: A Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):433-439. doi: 10.1097/BOT.0000000000002628.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture\n\nExclusion Criteria:\n\n* Pregnant women\n* Treatment with Arthroplasty\n* Patients who receive a peripheral nerve block\n* Patients who receive intra-op or post-op ketamine\n* Patients with concomitant TBI or MR\n* Polytrauma patients\n* Pathologic Fractures\n* Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider\n* Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance\n* Patients with prior extremity weakness resulting from stroke or other neurological condition\n* Prior or current history of narcotic use\n* Patients with advanced dementia\n* NYUMC Students, Residents, Faculty'}, 'identificationModule': {'nctId': 'NCT03693404', 'briefTitle': 'Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery', 'orgStudyIdInfo': {'id': '18-01019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal Anesthesia', 'description': 'Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.', 'interventionNames': ['Drug: Marcaine, Duramorph , ketorolac', 'Drug: Bupivacaine (Marcaine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Anesthesia', 'description': 'The control group will receive no injection into area surrounding the fracture site', 'interventionNames': ['Drug: General Anesthetics']}], 'interventions': [{'name': 'Marcaine, Duramorph , ketorolac', 'type': 'DRUG', 'description': 'Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.', 'armGroupLabels': ['Spinal Anesthesia']}, {'name': 'Bupivacaine (Marcaine)', 'type': 'DRUG', 'description': '0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.', 'armGroupLabels': ['Spinal Anesthesia']}, {'name': 'General Anesthetics', 'type': 'DRUG', 'description': 'Placebo group will only receive standard of care general anesthesia', 'armGroupLabels': ['General Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Philipp Leucht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'CSR'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}