chufangao/CTO huggingface dataset:
Clinical trial NCT05427630: Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
Official title: Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Pilot, Randomized, Double-blind, Placebo-controlled, Crossover, Dose-ranging Trial
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Inadequate funding
Enrollment: 20.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2023-02-15
Primary completion date: 2024-06-01
Completion date: 2024-06-01
Plan to share individual participant data: YES
IPD sharing description: Deidentified data will be shared in a manner TBD based on funding availability and journal requirements
IPD time frame: Beginning 1 year and ending 5 years after article publication
IPD access criteria: Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu
Clinical trial NCT03882918: An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome
Official title: An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome
Acronym: ELARA
Sponsor: Ovid Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 125.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-31
Primary completion date: 2021-06-04
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT04767698: Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis
Official title: Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The funding source decided to stop funding the study.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-01
Primary completion date: 2022-05-10
Completion date: 2022-05-10
Baseline population: No data was collected because the trial was prematurely terminated
Limitations and caveats: Study was prematurely terminated and therefore there was no data collected nor analysis performed.
Plan to share individual participant data: NO
Clinical trial NCT04373603: Use of Tranexamic Acid in Facial Fillers
Official title: Randomized Controlled Trial Evaluating the Co-Administration of HA and TXA in Facial Filler
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study closed prior to opening to enrollment, due to funding availability for study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-31
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Plan to share individual participant data: NO
Clinical trial NCT04734873: CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
Official title: Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
Sponsor: Corvus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision. Not related to safety issues.
Enrollment: 46.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-02-25
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Baseline population: 42 participants were randomized however only 40 received study treatment.
Limitations and caveats: The study was terminated due to enrollment difficulties and, as a result, some of the originally planned efficacy analyses could not be performed.
Clinical trial NCT03198078: Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Official title: A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 316.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-06-30
Primary completion date: 2023-04-03
Completion date: 2023-04-03
Baseline population: Randomized sample included all participants who were randomized into the trial.
Clinical trial NCT04035668: A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
Official title: An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)
Acronym: LOUiSSe
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision
Enrollment: 73.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-12
Primary completion date: 2021-11-23
Completion date: 2021-11-23
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 NCT03694197: Long Term Safety Study of PRALUENT
Official title: Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.
Enrollment: 1389.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-28
Primary completion date: 2020-04-08
Completion date: 2020-04-08
Baseline population: Demographic and other baseline characteristics were based on the data collected in R727-CL-1532 (NCT02957682). The baseline value was generally defined as the last available value before the first dose of double-blind study treatment in that study.
Clinical trial NCT04862416: Safety and Efficacy of R0.6C Vaccine
Official title: Safety, Tolerability and Plasmodium Falciparum Transmission-reducing Activity of R0.6C Vaccine Adjuvanted With Alhydrogel Alone or Combined With Matrix-M in Healthy Malaria-naïve Adults in the Netherlands
Acronym: STOP-TRANS
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-05-17
Primary completion date: 2022-06-29
Completion date: 2022-06-29
Clinical trial NCT03949673: Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
Official title: Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-08
Primary completion date: 2020-08-25
Completion date: 2020-08-25
Baseline population: Arthroplasty analysis set: All subjects who are enrolled in this study, have histological evaluation data and is based on the treatment received in their parent study (as treated).
Limitations and caveats: The study was anticipated to close in Feb 2021, but ended prematurely on 25 Aug 2020 (date of global last arthroplasty surgery for last subject enrolled) due to lack of enrollment.
Plan to share individual participant data: YES
IPD sharing description: All IPD that underlie publicly available results will be considered for sharing.
IPD time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Clinical trial NCT02534909: Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Official title: An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-09-09
Primary completion date: 2022-05-24
Completion date: 2022-05-24
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 NCT03921073: Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma
Official title: A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Terminated Funding
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-20
Primary completion date: 2021-09-28
Completion date: 2021-09-28
Plan to share individual participant data: NO
Clinical trial NCT03822715: NEOBREADS: Neoadjuvant Breast Diet Study
Official title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
Acronym: NEOBREADS
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-21
Primary completion date: 2021-08-17
Completion date: 2021-08-17
Clinical trial NCT02826681: Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
Official title: Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in Restless Legs Syndrome Patients With Iron-deficiency Anemia
Sponsor: American Regent, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-10
Primary completion date: 2021-09-04
Completion date: 2022-07-01
Plan to share individual participant data: NO
Clinical trial NCT04344548: Adoptive Cell Transfer for the Immunotherapy of COVID-19 in Colombia
Official title: Phase I / II Clinical Study of Immunotherapy Based on Adoptive Cell Transfer as a Therapeutic Alternative for Patients With COVID-19 in Colombia
Sponsor: Universidad Nacional de Colombia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The study did not get financed. Never get started.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-30
Primary completion date: 2020-06-30
Completion date: 2020-10-30
Plan to share individual participant data: NO
Clinical trial NCT03248128: Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
Official title: A Randomised, Double-blind, Parallel Group, Multicentre, Stratified, Study Evaluating the Efficacy and Safety of Once Daily Fluticasone Furoate/Vilanterol Inhalation Powder Compared to Once Daily Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Participants Aged 5 to 17 Years Old (Inclusive) Currently Uncontrolled on Inhaled Corticosteroids
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 906.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-10-20
Primary completion date: 2022-03-21
Completion date: 2022-03-21
Baseline population: Baseline Characteristic data are reported for 902 participants who received at least 1 dose of study medication creating the ITT Population.
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT03572257: Quetiapine Treatment for Pediatric Delirium
Official title: Prospective, Double-Blind, Randomized Controlled Trial of Quetiapine as a Treatment for Delirium in Critically Ill Children
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Closed due to inability to enroll
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-15
Primary completion date: 2020-02-27
Completion date: 2020-03-02
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04999488: Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older Adults With Sarcopenia
Official title: Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older
Acronym: COQ10
Sponsor: AdventHealth Translational Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Drug manufacturing update. Study site will proceed with study in future.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-12-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Clinical trial NCT03818815: A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Official title: A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Sponsor: Novus Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 103.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-21
Primary completion date: 2020-03-09
Completion date: 2020-03-26
Plan to share individual participant data: NO
Clinical trial NCT03711318: Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Official title: Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: continuing study was no longer feasible
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-01
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Baseline population: Participants who consented to and initiated study
Clinical trial NCT04305405: PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
Official title: An Open-label Study to Evaluate the Pharmacokinetics and Pharmacodynamics and Long-term Safety of Benralizumab Administered Subcutaneously in Children With Severe Eosinophilic Asthma
Acronym: TATE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-21
Primary completion date: 2022-09-12
Completion date: 2022-09-12
Baseline population: The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab.
Clinical trial NCT05848843: A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations
Official title: A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: 0 participant accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-25
Primary completion date: 2024-01-16
Completion date: 2024-01-16
Clinical trial NCT04650893: The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
Official title: The Effect of Intravenous Non-steroidal Anti-inflammatory Drugs and Intravenous Corticosteroids on the Likelihood of Dysphagia and Dysphonia Following Anterior Cervical Discectomy and Fusion
Sponsor: University of Nebraska (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Poor compliance with data collection - too many intervals.
Enrollment: 33.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-02
Primary completion date: 2023-12-08
Completion date: 2023-12-08
Baseline population: Baseline was less than desired due to closure of study because follow-up was poor.
Plan to share individual participant data: NO
Clinical trial NCT02962388: The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line
Official title: A Randomized, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With High Risk Essential Thrombocythemia, Who Are Resistant or Intolerant to Hydroxyurea: A FIM Study
Sponsor: French Innovative Leukemia Organisation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: not enough recruitment
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-03
Primary completion date: 2021-06-28
Completion date: 2021-06-28
Plan to share individual participant data: YES
IPD sharing description: e crf
Clinical trial NCT04057365: Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)
Official title: A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on a Simon 2-stage design, this study did not meet response criteria to proceed to stage 2.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-07
Primary completion date: 2022-09-25
Completion date: 2022-09-25
Baseline population: Based on a Simon 2-stage design, this study did not meet response criteria to proceed beyond the safety run-in group.
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT04066088: Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
Official title: Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: PI departure from institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-01
Primary completion date: 2020-08-21
Completion date: 2020-08-21
Clinical trial NCT04871815: Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.
Official title: Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers.
Sponsor: Cellular Sciences, inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-27
Primary completion date: 2022-03-07
Completion date: 2022-03-07
Plan to share individual participant data: NO
Clinical trial NCT02589340: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Official title: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Acronym: BUS-PD
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2021-02-23
Completion date: 2021-02-23
Clinical trial NCT04922957: A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)
Official title: A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)
Sponsor: Enlivex Therapeutics Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: strategic reprioritization
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2022-04-01
Completion date: 2024-03-11
Plan to share individual participant data: NO
IPD sharing description: Patient data will not contain any information which would make the patient identifiable. Data will be processes and shared using patient study number only.