chufangao/CTO huggingface dataset:
Clinical trial NCT04379713: 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1511.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-21
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Baseline population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received any incorrect study vaccination during the study was excluded.
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 NCT03103971: huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
Official title: A Two-Stage Phase 1 Open-Label Study of huJCAR014, CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells Bearing a Human Binding Domain, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Acute Lymphocytic Leukemia
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated due to slow enrollment and end of funding
Enrollment: 55.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-03
Primary completion date: 2023-03-23
Completion date: 2024-03-23
Plan to share individual participant data: NO
Clinical trial NCT04428047: Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma
Official title: A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma
Acronym: ICING
Sponsor: UNICANCER (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-04
Primary completion date: 2021-09-04
Completion date: 2022-01-07
Plan to share individual participant data: NO
IPD sharing description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Clinical trial NCT02627963: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
Official title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
Sponsor: AVEO Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 350.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-24
Primary completion date: 2018-10-04
Completion date: 2021-06-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02666742: DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
Official title: SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)
Acronym: STROKE-VT
Sponsor: Kansas City Heart Rhythm Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 246.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-16
Primary completion date: 2020-05-01
Completion date: 2021-04-30
Baseline population: Patients undergoing VT or PVC ablation are enrolled into the study. Baseline characteristics of patients including demographics, comorbidities, cardiac function etc were collected and analyzed
Limitations and caveats: Our results should be considered in light of several significant limitations. An important limitation was the lack of long-term follow-up and quality-of-life and neurocognitive function information. Another methodological limitation of the outcomes was that the ASA group did not get a loading dose, perhaps the delay in achieving the therapeutic effects in denovo ASA initiation could increase the risk of events.
Plan to share individual participant data: NO
Clinical trial NCT02959658: Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
Official title: Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
Acronym: FUMAPMS
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 54.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-31
Primary completion date: 2019-12-21
Completion date: 2020-12-09
Plan to share individual participant data: NO
Clinical trial NCT05293106: Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
Official title: Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
Acronym: PEDITREC
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulty recruiting and enrolling subjects.
Enrollment: 9.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-07-05
Primary completion date: 2023-09-17
Completion date: 2023-09-27
Limitations and caveats: Due to difficulty in recruiting and enrolling subjects, only descriptive statistics were used to describe the 9 enrolled subjects.
Plan to share individual participant data: NO
Clinical trial NCT04365400: Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
Official title: A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
Acronym: TRIAGE
Sponsor: Afimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial prematurely terminated on 03 May 2022 due to the results from an interim analysis indicating a lack of efficacy in the study population.
Enrollment: 233.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-13
Primary completion date: 2022-05-03
Completion date: 2022-05-03
Baseline population: Safety Analysis Set: The SAS consists of all patients who received at least one dose of the study medication.
Plan to share individual participant data: NO
Clinical trial NCT04530747: Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea
Official title: Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea
Acronym: MET-OSA
Sponsor: Pennington Biomedical Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Recall of positive airway pressure (PAP) device.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-28
Primary completion date: 2021-11-30
Completion date: 2021-11-30
Limitations and caveats: Early termination due to PAP recall.
Clinical trial NCT01468311: Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
Official title: Phase I/II Trial of Yttrium-90-labeled Daclizumab (Anti-CD25) Radioimmunotherapy With High-dose BEAM Chemotherapy and Autologous Hematopoietic Stem Cell Rescue in Recurrent and Refractory Hodgkin's Lymphoma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Poor enrollment and ability to radioconjugate Daclizumab. Neither Center for Cancer Research (CCR) or Nuclear Medicine/Radiology wanted to do the facilities upgrade and hire personnel needed to radioconjugate the drug at the Clinical Center.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-10-11
Primary completion date: 2014-11-16
Completion date: 2020-10-22
Plan to share individual participant data: NO
Clinical trial NCT03492138: Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
Official title: A Phase I/II Study of the Addition of Ixazomib to ONC201 and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-26
Primary completion date: 2020-01-14
Completion date: 2020-01-14
Plan to share individual participant data: UNDECIDED
IPD sharing description: Data and safety will be monitored using an internal Data and Safety Monitoring Plan (DSMP) led by the PI. Other members involved with the review will include sub-Investigators, the myeloma research program manager, and clinical research coordinators. All of these individuals have experience in the routine clinical care as well clinical research and monitoring of subjects with multiple myeloma. A statistician will also be involved with the review.
Clinical trial NCT04852978: COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
Official title: A Phase 2 Randomized, Open-Label, Parallel Group Study to Assess the Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 295.0 (ACTUAL)
Number of arms: 12.0
Start date: 2021-04-29
Primary completion date: 2022-11-21
Completion date: 2022-11-21
Baseline population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Clinical trial NCT03930732: Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
Acronym: BOREAS
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 939.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-15
Primary completion date: 2023-02-08
Completion date: 2023-05-02
Baseline population: The Randomized population consisted of any participant who was allocated to a randomized treatment regardless of whether the treatment kit was used.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04994535: A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 426.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-10
Primary completion date: 2023-06-14
Completion date: 2023-06-14
Baseline population: Baseline analyses were performed on the ITT population, consisting of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT03531827: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment
Official title: A Single Arm Phase II Study Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in Patients With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was closed for toxicity.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-26
Primary completion date: 2021-05-15
Completion date: 2021-06-01
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~All collected IPD will be shared with collaborators under the terms of collaborative agreements.
IPD time frame: Clinical data available during the study and indefinitely.
IPD access criteria: Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Clinical trial NCT03499353: Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Official title: A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study was terminated based on Pfizer's change in clinical development strategy not related to safety and efficacy.
Enrollment: 61.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-27
Primary completion date: 2020-09-23
Completion date: 2020-09-23
Baseline population: Baseline analysis population included all participants who received any amount of talazoparib.
Limitations and caveats: The study was prematurely terminated by the sponsor due to a change in clinical development strategy not related to safety or efficacy after all participants completed safety follow-up.
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 NCT05116774: BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy
Official title: A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy
Acronym: REDEEM-1
Sponsor: BioCryst Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-06
Primary completion date: 2023-09-14
Completion date: 2023-09-14
Plan to share individual participant data: NO
Clinical trial NCT03041311: Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
Official title: Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)
Sponsor: G1 Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns.
Enrollment: 107.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-29
Primary completion date: 2018-08-17
Completion date: 2020-10-29
Limitations and caveats: Limitation of the trial is small numbers of subjects, since it is a Phase 2 clinical trial.~Small sample size may have reduced the ability to observe statistically significant treatment effects on secondary myelopreservation measures (i.e. occurrence of FN AEs, infections and antibiotics usage).
Plan to share individual participant data: NO
Clinical trial NCT04946864: A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer
Official title: A Phase Ib/II Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination With Systemic Anti-cancer Agents in Patients With ER Positive Breast Cancer or Advanced Solid Tumors.
Sponsor: Ascentage Pharma Group Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Company Decision
Enrollment: 65.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-08-13
Primary completion date: 2024-08-12
Completion date: 2024-10-01
Plan to share individual participant data: NO
Clinical trial NCT03865563: Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Official title: Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: We need to make significant adjustments to proposed drug and its delivery method
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-31
Primary completion date: 2021-06-30
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT03849456: Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder
Official title: Safety and Tolerability of GWP42006 in Children and Young Adults With Autism Spectrum Disorder
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to enrollment challenges during COVID-19 pandemic.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-07
Primary completion date: 2020-05-26
Completion date: 2020-05-26
Plan to share individual participant data: NO
Clinical trial NCT05369390: A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
Official title: Safety, Tolerability and Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 144.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-11
Primary completion date: 2024-01-09
Completion date: 2024-01-09
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT01990352: Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy
Official title: A Single Arm Phase II Trial to Assess Association of BRCA1 Protein Expression With Overall Response Rate in Patients With Metastatic Breast Cancer on Pegylated Liposomal Doxorubicin
Sponsor: University of Arizona (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The PI determined that study specimens being obtained did not yield sufficient data to analyze the prespecified outcome measures and decided to terminate the study prior to meeting enrollment goals.
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-11-05
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Limitations and caveats: The trial was started with preliminary data on BRCA1 immunohistochemistry assay developed with a collaborator. The assay, in the trial, due to differences in the timeline on when the tumor tissue was collected, the variability in the tumor tissue processing, storage, and age of the samples, the assay did not work on the samples as projected. Subsequently, due to COVID-19 and the challenges with the assay performance, the collaborator discontinued further development of the assay.
Clinical trial NCT03569007: Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
Sponsor: 9 Meters Biopharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Trial terminated by Sponsor
Enrollment: 307.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-29
Primary completion date: 2022-07-21
Completion date: 2022-07-21
Plan to share individual participant data: NO