chufangao/CTO huggingface dataset:
Clinical trial NCT04542330: Using BCG to Protect Senior Citizens During the COVID-19 Pandemic
Official title: Using BCG Vaccine to Enhance Non-specific Protection of Senior Citizens During the COVID-19 Pandemic. A Randomized Clinical Trial.
Sponsor: Bandim Health Project (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1700.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2023-01-11
Completion date: 2023-01-11
Plan to share individual participant data: YES
IPD sharing description: Non-identifiable individual data can be shared on the basis of a data sharing proposal sent to cbenn@health.sdu.dk
IPD time frame: When follow-up has been completed and the dataset have been closed
IPD access criteria: Per justified request on email (cbenn@health.sdu.dk)
Clinical trial NCT05757648: Buffered Local Anesthetic
Official title: Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study
Sponsor: University Hospitals Cleveland Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-08
Primary completion date: 2023-06-12
Completion date: 2023-06-12
Plan to share individual participant data: NO
Clinical trial NCT03285165: Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients
Official title: Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients With and Without Traumatic Brain Injury.
Acronym: DEXSEDATION
Sponsor: Assiut University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: NO AVAILABLE FUND
Enrollment: 60.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2017-09-14
Primary completion date: 2021-09-16
Completion date: 2021-09-16
Plan to share individual participant data: NO
Clinical trial NCT05134727: Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants
Official title: A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Oral AZD5055 Following Single and Multiple Ascending Doses
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-18
Primary completion date: 2023-03-31
Completion date: 2023-03-31
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in a sponsor approved tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04229771: Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?
Official title: Does Administration of Proparacaine Hydrochloride 0.5% Ophthalmic Solution Prior to Canalicular Probing and Irrigation Decrease Patient Discomfort
Sponsor: William Beaumont Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: slow enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Baseline population: No participants randomized to the group Participants who received proparacaine hydrochoride solution in the right eye and placebo in the left eye.
Plan to share individual participant data: NO
IPD sharing description: No individual participant data to be shared
Clinical trial NCT04074330: A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma
Official title: Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Enrolment Challenges
Enrollment: 38.0 (ACTUAL)
Number of arms: 10.0
Start date: 2019-10-15
Primary completion date: 2023-04-26
Completion date: 2023-04-26
Baseline population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
Limitations and caveats: The study was terminated due to enrollment challenges.
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 NCT05219513: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Official title: An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to sponsor portfolio re-alignment.
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-18
Primary completion date: 2024-07-17
Completion date: 2024-07-17
Plan to share individual participant data: NO
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
Clinical trial NCT04388176: Cold Challenge With C21 in RP
Official title: A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)
Sponsor: Vicore Pharma AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-03
Primary completion date: 2020-12-14
Completion date: 2020-12-14
Clinical trial NCT04905121: Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Official title: An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Sponsor: Beckley Psytech Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Unable to recruit patient population
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-08-11
Primary completion date: 2022-04-22
Completion date: 2022-04-22
Plan to share individual participant data: NO
IPD sharing description: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
Clinical trial NCT03118232: Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Official title: Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Acronym: PROTECT
Sponsor: University of California, Irvine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 13952.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-03
Primary completion date: 2023-10-10
Completion date: 2023-10-10
Plan to share individual participant data: NO
IPD sharing description: The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.
Clinical trial NCT03727841: Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial, and Spinal Cord Ependymoma
Official title: Phase II Clinical Trial of Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The pharmaceutical company decided to close their program evaluating the study agent, Marizomib.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-22
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Plan to share individual participant data: YES
IPD sharing description: 1. Biomedical Translational Research Information System (BTRIS): All IPD recorded in the medical record will be shared with intramural investigators upon request.~2. Database of Genotypes and Phenotypes (dbGaP): All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD time frame: BTRIS: Clinical data available during the study and indefinitely. dbGaP: Genomic data are available once genomic data are uploaded per protocol genomic data sharing (GDS) plan for as long as database is active.
IPD access criteria: BTRIS: Clinical data will be made available via subscription to BTRIS and with the permission of the study principal investigator (PI).~dbGaP: Genomic data are made available via dbGaP through requests to the data custodians.
Clinical trial NCT03669640: A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study was discontinued due to an interim analysis which indicated that ralmitaront was unlikely to meet its primary endpoint.
Enrollment: 131.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-04
Primary completion date: 2023-03-12
Completion date: 2023-03-12
Clinical trial NCT04527549: Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma
Official title: The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma With Elevated LDH
Sponsor: Eastern Cooperative Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2024-01-08
Completion date: 2024-01-08
Plan to share individual participant data: YES
IPD sharing description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Clinical trial NCT05248880: A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
Official title: A Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines in Toxin-Naïve Subjects
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 309.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-08
Primary completion date: 2023-02-01
Completion date: 2023-02-01
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 NCT03632798: Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer
Official title: Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Acronym: ACSCO
Sponsor: Cordgenics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Slow enrollment
Enrollment: 300.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-08-01
Primary completion date: 2024-12-30
Completion date: 2024-12-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04611152: A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)
Acronym: GLEAM
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study did not meet primary endpoint
Enrollment: 460.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2023-05-11
Completion date: 2023-08-31
Baseline population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.
Clinical trial NCT03332212: A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin
Official title: EMPA-VISION: A Randomised, Double-blind, Placebo-controlled, Mechanistic Cardiac Magnetic Resonance Study to Investigate the Effects of Empagliflozin Treatment on Cardiac Physiology and Metabolism in Patients With Heart Failure
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-01
Primary completion date: 2020-05-21
Completion date: 2020-05-28
Baseline population: Randomised set (RS): This set included all patients who were randomised to study treatment, in line with the intention-to-treat principle.
Limitations and caveats: Due to the suspension of face-to-face contact imposed in March 2020 to restrict transmission of COVID-19, the number of patients included in the analysis of efficacy for the Heart failure with preserved ejection fraction was substantially reduced, which meant that this cohort was also under powered (reduced from 80% to 70%) for the planned analysis of the primary endpoint.
Clinical trial NCT04501952: Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
Official title: A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.
Enrollment: 584.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-18
Primary completion date: 2021-05-06
Completion date: 2021-05-06
Baseline population: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT02498977: Liver Immunosuppression Free Trial
Official title: Prospective Randomised Marker-based Trial to Assess the Clinical Utility and Safety of Biomarker-guided Immunosuppression Withdrawal in Liver Transplantation
Acronym: LIFT
Sponsor: King's College London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Primary endpoint not reached.
Enrollment: 116.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-10-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT02296671: Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers
Official title: Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Was unable to accrue any patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-02-28
Primary completion date: 2018-09-30
Completion date: 2022-02-28
Clinical trial NCT04441788: A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)
Official title: A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis
Sponsor: Ionis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business Decision to Terminate Study
Enrollment: 60.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-22
Primary completion date: 2021-04-27
Completion date: 2021-08-09
Baseline population: Safety population included all the participants who were randomized and received at least 1 dose of study drug.
Limitations and caveats: The study was terminated based on the toxicology findings from a 9-month study and participants who had not completed the treatment period were instructed to terminate dosing and return for an end of study visit, followed by the 10-week follow-up period.
Plan to share individual participant data: NO
Clinical trial NCT04408664: Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.
Official title: WP3-Influence of Cromones on EVH-test in Young (Elite) Athletes Who Tested Positive for EIB (=Exercise Induced Bronchoconstriction)
Sponsor: Universitaire Ziekenhuizen KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient accrual rate
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-06
Primary completion date: 2023-06-28
Completion date: 2023-08-01
Plan to share individual participant data: NO
IPD sharing description: data will be analysed and grouped before release
Clinical trial NCT03934216: Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 131.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-01
Primary completion date: 2021-06-13
Completion date: 2023-04-04
Clinical trial NCT04847583: A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients
Official title: A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease
Sponsor: Qurient Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor's Decision
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-29
Primary completion date: 2022-02-11
Completion date: 2022-02-11
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04391179: Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Official title: Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Acronym: DICER
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 99.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-31
Primary completion date: 2021-02-22
Completion date: 2021-02-22
Plan to share individual participant data: NO