chufangao/CTO huggingface dataset:
Clinical trial NCT04489420: Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
Official title: A Phase I Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) in Adults With Recurrent Glioblastoma Multiforme (GBM)
Acronym: CYNK001GBM01
Sponsor: Celularity Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2021-08-10
Completion date: 2021-08-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03051516: HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
Official title: HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was terminated early due to futility.
Enrollment: 188.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Baseline population: Participants who have completed Enrollment Visit and had at least 30 days follow-up after the initial dose of vaccine (n=185) were included in the intention-to-treat analysis and are considered part of the Baseline Analysis Population. Three participants (2 in Arm I/vaccine and 1 in Arm II/placebo) were excluded from analysis due to completing only one vaccination before study exit.
Limitations and caveats: An interim analysis found the intervention to be futile. Therefore, the VIVA trial was ended effective July 31st, 2022, for the University of Washington clinic, and December 31st, 2022, for the University of Alabama Birmingham clinic. Participants were offered the choice of continuing any outstanding visits until the end of the study at the respective sites.
Plan to share individual participant data: NO
Clinical trial NCT05232123: Cannabidiol Effects on Cardiovascular System and Exercise Responses
Official title: Cannabidiol Effects on Cardiovascular System and Exercise Responses
Sponsor: Castleton University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: did not receive funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-07-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT04264819: Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration
Official title: A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)
Acronym: SWIFT
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 295.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-14
Primary completion date: 2022-10-05
Completion date: 2023-05-10
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 NCT05010954: Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer
Official title: A Multi-center, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 Compared to Lansoprazole in the Treatment of Duodenal Ulcer in Chinese Patients for up to 6 Weeks
Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 400.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-18
Primary completion date: 2022-09-28
Completion date: 2022-09-28
Clinical trial NCT04895046: Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma
Official title: Molecularly Driven, Immune-Based, Maintenance Niraparib and Dostarlimab in Advanced Stage Cholangiocarcinoma
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funder decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-11
Primary completion date: 2022-09-30
Completion date: 2023-09-30
Plan to share individual participant data: NO
Clinical trial NCT04331054: Protective Role of Inhaled Steroids for Covid-19 Infection
Official title: Protective Role of Inhaled Steroids for Covid-19 Infection
Acronym: INHASCO
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient recruitment
Enrollment: 146.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-13
Primary completion date: 2021-05-28
Completion date: 2021-05-28
Clinical trial NCT04412538: Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years
Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 942.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-05-15
Primary completion date: 2020-08-10
Completion date: 2021-08-31
Clinical trial NCT05607342: Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate
Official title: Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate (PORT-MAP)
Acronym: PORT-MAP
Sponsor: University of Kansas Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Development of the drug program has been discontinued
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-03
Primary completion date: 2023-09-22
Completion date: 2023-11-06
Clinical trial NCT03015792: Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant
Official title: Phase I/II Trial of Ibrutinib, Dexamethasone, and Lenalidomide as Initial Therapy for Transplant Ineligible Multiple Myeloma Patients
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Per CS0139535 -submitter stated we can update status to Admin complete- low accrual reasoning
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-10
Primary completion date: 2022-10-18
Completion date: 2022-10-18
Clinical trial NCT04042740: Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
Official title: Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
Acronym: PURGE-C
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-20
Primary completion date: 2023-05-18
Completion date: 2023-08-22
Baseline population: All eligible participants who initiated study treatment
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification.
IPD time frame: Beginning 3 months following publication and throughout period of funding of the ACTG Network by NIH.
IPD access criteria: * With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.
Clinical trial NCT02560935: Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II
Official title: Primary Prevention of Stroke in Children With Sickle Cell Disease in Sub-Saharan Africa II
Acronym: SPRING
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 440.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-19
Primary completion date: 2020-03-03
Completion date: 2020-03-03
Plan to share individual participant data: NO
Clinical trial NCT05687903: A Study of TAK-861 in Participants With Narcolepsy Type 1
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 112.0 (ACTUAL)
Number of arms: 5.0
Start date: 2023-01-09
Primary completion date: 2023-12-14
Completion date: 2023-12-14
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03715153: Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Official title: Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The 6-month efficacy analysis did not show any significant difference between bumetanide versus placebo in the treatment of ASD in the overall studied population. No unexpected safety concerns were identified.
Enrollment: 211.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-04
Primary completion date: 2021-10-26
Completion date: 2021-10-26
Limitations and caveats: The sponsor decided to stop the S95008 development and prematurely discontinue the extension period. This decision was not related to unexpected safety concerns.
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT04603365: Pamiparib and Temozolomide for the Treatment of Hereditary Leiomyomatosis and Renal Cell Cancer
Official title: A Phase 2 Study of Pamiparib (BGB-290) Plus Temozolomide for Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC)
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-18
Primary completion date: 2023-05-07
Completion date: 2023-05-07
Clinical trial NCT04919096: Study of SCB-420 in Subjects With Neovascular Age-related Macular Degeneration
Official title: A Phase 1, Randomized, Double-Masked, Parallel Group, Multicenter, Pilot Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SCB-420 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration
Sponsor: Clover Biopharmaceuticals AUS Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Due to an internal decision to prioritise its development pipeline, Clover have decided to close down study CLO-SCB-420-001. This was a corporate decision and not the results of new data or information arising related to SCB-420
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-30
Primary completion date: 2022-09-30
Completion date: 2023-01-31
Clinical trial NCT03693846: Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Official title: A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow enrollment and lack of efficacy
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-15
Primary completion date: 2021-03-06
Completion date: 2021-03-06
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT03302221: Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound
Official title: Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management
Sponsor: China Medical University, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-10-15
Primary completion date: 2020-08-20
Completion date: 2020-09-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03999658: A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies
Official title: An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies.
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-03-31
Primary completion date: 2024-01-31
Completion date: 2024-07-31
Plan to share individual participant data: NO
Clinical trial NCT04023721: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor
Official title: A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With Chronic Hepatitis B Virus and Receiving or Stopping Treatment With a Nucleoside/Nucleotide Inhibitor
Sponsor: F-star Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Safety
Enrollment: 64.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-18
Primary completion date: 2020-07-16
Completion date: 2020-07-16
Clinical trial NCT02678143: Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease
Official title: A Pilot Study of Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Closed early due to competing studies
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-26
Primary completion date: 2020-04-03
Completion date: 2021-11-16
Plan to share individual participant data: NO
Clinical trial NCT02108964: A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
Official title: A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 225.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-06
Primary completion date: 2018-03-22
Completion date: 2023-08-15
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 NCT04853355: Non-Responsive Diabetic Macular Edema and Spironolactone
Official title: Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-31
Primary completion date: 2022-09-30
Completion date: 2022-10-31
Plan to share individual participant data: YES
IPD sharing description: Available upon request.
IPD time frame: 12 months after completion date
IPD access criteria: Contact Principal investigator
Clinical trial NCT03112720: Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache
Official title: A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: no enrollment after covid pandemic
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-30
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
Clinical trial NCT02606461: Selinexor in Advanced Liposarcoma
Official title: A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Acronym: SEAL
Sponsor: Karyopharm Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 342.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-01-04
Primary completion date: 2020-10-28
Completion date: 2021-10-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT00433342: The Effect of Antimicrobial Therapy on the Serum Level of P-cresol in Peritoneal Dialysis Patients
Official title: Study on the Effect of Flucloxacillin on the Serum Level of P-cresol in Peritoneal Dialysis Patients
Sponsor: Universitaire Ziekenhuizen KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2006-03-31
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Clinical trial NCT04140279: A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension
Official title: Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Ocular Hypertensive Subjects
Sponsor: Bausch & Lomb Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: It never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-13
Primary completion date: 2023-08-31
Completion date: 2023-08-31
Clinical trial NCT03535194: A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1484.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-06-26
Primary completion date: 2020-03-05
Completion date: 2020-06-03
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.