chufangao/CTO huggingface dataset:
Clinical trial NCT04387071: CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma
Official title: The Seena Magowitz Phase IB/II Trial of CMP-001 (a TLR9 Agonist) in Combination With INCAGN01949 (an Activating Anti-OX40 Antibody) for In Situ Intratumoral Injection for Patients With Stage IV Pancreatic and Other Cancers Except Melanoma
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study drug no longer available
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-29
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Clinical trial NCT01118026: Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
Official title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL)
Sponsor: Alliance for Clinical Trials in Oncology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 101.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-09-30
Primary completion date: 2020-09-30
Completion date: 2021-09-29
Clinical trial NCT04588688: Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Official title: Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-05
Primary completion date: 2021-08-01
Completion date: 2021-08-01
Plan to share individual participant data: NO
Clinical trial NCT01369212: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
Official title: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Acronym: HBRN
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 201.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-11-30
Primary completion date: 2021-03-08
Completion date: 2021-03-08
Plan to share individual participant data: YES
IPD sharing description: Data will be available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository https://repository.niddk.nih.gov/home/
Clinical trial NCT02997202: A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 356.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-16
Primary completion date: 2023-01-07
Completion date: 2023-05-09
Baseline population: Intention-to-Treat (ITT) population: All randomized participants were included in this population
Plan to share individual participant data: YES
IPD sharing description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Clinical trial NCT04653389: Perioperative Therapy for Hepatocellular Carcinoma
Official title: Perioperative Multidisciplinary Therapy for Technically Resectable Hepatocellular Carcinoma With Vein Thrombosis: An Exploratory Clinical Trail
Sponsor: Zhejiang University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The treatment efficacy was not satisfactory.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-26
Primary completion date: 2021-10-01
Completion date: 2021-12-01
Plan to share individual participant data: NO
Clinical trial NCT02644967: A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma
Official title: A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma (ILLUMINATE-204)
Sponsor: Idera Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-12-31
Primary completion date: 2020-02-29
Completion date: 2021-05-31
Baseline population: Includes all participants who received at least 1 dose of study treatment.
Limitations and caveats: The analysis populations, as defined in section 6 of the Statistical Analysis Plan, analyzed participants enrolled in the phase 2 study (N=44) and participants rolled in from the phase 1, 8 mg Tilso/Ipi population (N=9).
Plan to share individual participant data: NO
Clinical trial NCT03224585: Treatment of Acute Pericarditis With Anakinra
Official title: Treatment of Acute Pericarditis With Anakinra
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated because dramatic benefits seen during the first 24 hours of drug administration combined with COVID restrictions on research activities suggested it was both unethical and unnecessary to complete the planned enrollment
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-11
Primary completion date: 2020-02-01
Completion date: 2020-02-01
Clinical trial NCT05273658: Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests
Official title: Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Termination of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2022-08-31
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Clinical trial NCT04771143: Study to Assess Safety, Tolerability, and Interactions of Cocaine and Oral AFQ056
Official title: A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, and Potential Interactions of Oral AFQ056 Given Concurrently With Cocaine
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: study terminated/withdrawn before FPFV (no patients enrolled)
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-21
Primary completion date: 2022-01-03
Completion date: 2022-01-03
Plan to share individual participant data: NO
Clinical trial NCT05014919: Vortioxetine to Prevent Return of Symptoms in Children With Depression
Official title: A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated based on new efficacy data from another study.
Enrollment: 35.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-08-10
Primary completion date: 2022-03-31
Completion date: 2022-04-28
Baseline population: All-patients-enrolled (APES): all participants enrolled to the 12-week open-label treatment period who took at least 1 dose of study drug. Full analysis set (FAS): all participants randomized to the 26-week double-blind treatment period who took at least 1 dose of double-blind study drug.
Limitations and caveats: The study was terminated based on new efficacy data from another study. The main primary and secondary efficacy objectives were not assessed due to termination of the study and the limited number of participants who completed the double-blind period.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03272217: Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer
Official title: A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funder decision
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-13
Primary completion date: 2021-05-27
Completion date: 2022-03-17
Plan to share individual participant data: NO
Clinical trial NCT03481959: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Official title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Acronym: METHACAN
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: insufficient recrutement in the study
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-07
Primary completion date: 2020-09-01
Completion date: 2020-09-01
Plan to share individual participant data: NO
Clinical trial NCT02315066: Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
Official title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 174.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-23
Primary completion date: 2020-11-12
Completion date: 2020-11-12
Baseline population: The baseline analysis population included all enrolled patients who received at least one full or partial IV infusion of study drug PF-04518600.
Limitations and caveats: A decision was made by the sponsor to terminate further enrollment to the study on 03 Oct 2018 due to business reasons. The decision to terminate study enrollment was not based on any safety or regulatory concerns.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04507204: Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States
Acronym: RE-DAX
Sponsor: Purdue Pharma LP (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: (due to administrative reasons not related to efficacy or safety.)
Enrollment: 267.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-30
Primary completion date: 2021-12-22
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT04232878: A Single Ascending Dose Trial of CVL-936 in Healthy Subjects
Official title: A Phase 1, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Ascending Doses of CVL-936 In Healthy Subjects
Sponsor: Cerevel Therapeutics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sufficient data has been obtained to meet current objectives
Enrollment: 10.0 (ACTUAL)
Number of arms: 14.0
Start date: 2019-12-16
Primary completion date: 2020-03-06
Completion date: 2020-05-21
Plan to share individual participant data: NO
Clinical trial NCT03730662: A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Official title: Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)
Acronym: SURPASS-4
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2002.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-11-20
Primary completion date: 2021-01-22
Completion date: 2021-04-22
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT02188368: Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients
Official title: A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen
Sponsor: Oncotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-07-07
Primary completion date: 2020-10-23
Completion date: 2020-10-23
Clinical trial NCT02907359: Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
Official title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents
Sponsor: Astex Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 417.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-13
Primary completion date: 2020-03-31
Completion date: 2020-11-30
Baseline population: The Efficacy Analysis Set included all participants randomly assigned to the study treatment.
Plan to share individual participant data: NO
Clinical trial NCT04707534: Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19
Official title: Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19
Sponsor: University of Oklahoma (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 110.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-21
Primary completion date: 2021-12-31
Completion date: 2022-03-04
Clinical trial NCT02696031: Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs
Acronym: PREVENT
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 555.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-04-29
Primary completion date: 2019-07-01
Completion date: 2021-03-11
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT04497987: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study
Acronym: BLAZE-2
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1180.0 (ACTUAL)
Number of arms: 9.0
Start date: 2020-08-02
Primary completion date: 2021-01-16
Completion date: 2021-05-20
Baseline population: All randomized participants who received at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03269695: Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor changed R\&D strategy and priority.
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-20
Primary completion date: 2021-01-07
Completion date: 2021-01-07
Baseline population: All participants who received at least one dose of randomized treatment were included in the baseline analysis population.
Limitations and caveats: The study was terminated after an interim analysis, due to efficacy being considered unlikely to meet the projected target.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05294263: Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans
Official title: Varenicline for Comorbid Tobacco and Cannabis Use in Veterans
Acronym: Vet Cat
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Despite the numerous approaches below, we have not been successful in identifying a recruitment pathway that would ensure feasibility of study continuation. We have had multiple meetings with CSR\&D leadership to discuss our study progress
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-17
Primary completion date: 2024-07-17
Completion date: 2024-07-17
Plan to share individual participant data: NO
Clinical trial NCT03353428: Intervention of Engineered Immune Effector T Cells Against Lung Cancer
Official title: Interventional Treatment of Lung Cancer (LC) With LC Specific Immune Lymphocytes (LC-CTLs)
Sponsor: Shenzhen Geno-Immune Medical Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: combine with NCT03356808
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-15
Primary completion date: 2019-01-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT03774875: A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life
Official title: A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life
Acronym: EMBRACE
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 277.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-28
Primary completion date: 2021-02-01
Completion date: 2021-11-03
Baseline population: All randomized participants
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.