chufangao/CTO huggingface dataset:
Clinical trial NCT03991299: Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects
Official title: Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-29
Primary completion date: 2022-02-11
Completion date: 2022-02-11
Baseline population: Participants analysis not done.
Limitations and caveats: Early termination leading to small numbers of subjects enrolled.~Technical problems due to limited enrollment leading to uninterpretable data.
Plan to share individual participant data: NO
Clinical trial NCT04224688: A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Official title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Acronym: myOpportunITy2
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Strategic Business Decision; Not a safety decision
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-03
Primary completion date: 2022-04-25
Completion date: 2022-05-05
Baseline population: Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT03626662: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 79.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-30
Primary completion date: 2023-04-18
Completion date: 2023-04-18
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT05597722: Addressing Cognitive Fog in Long-COVID-19 Patients
Official title: Randomized Study to Evaluate Strategies to Address Cognitive Fog in Long-COVID-19 Patients
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to the evolving nature of COVID-related cognitive fog, it was determined that the study would be terminated at this time. The team agreed that it isn't feasible to collect enough data to evaluate the efficacy of the treatments.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-04
Primary completion date: 2023-05-18
Completion date: 2023-05-18
Baseline population: The study was terminated prior to any baseline assessments being analyzed.
Plan to share individual participant data: NO
IPD sharing description: Individual participant data will not be shared. Data is shared at the aggregate level.
Clinical trial NCT05354856: The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
Official title: The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruiting issues
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-11
Primary completion date: 2023-12-29
Completion date: 2023-12-30
Clinical trial NCT04109066: Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Acronym: CheckMate 7FL
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 521.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-20
Primary completion date: 2023-01-16
Completion date: 2023-12-27
Clinical trial NCT05594667: Effect of SSRIs on Response to Psilocybin Therapy
Official title: Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD)
Sponsor: Cybin Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-01
Primary completion date: 2023-03-14
Completion date: 2023-03-14
Plan to share individual participant data: NO
Clinical trial NCT02674958: Mobilization of Endothelial Progenitor Cells and Aspirin
Official title: Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin
Acronym: TROPHIC 3
Sponsor: Ottawa Heart Institute Research Corporation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Covid-19 pandemic
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-31
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02387229: Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF
Official title: Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF (BRAIN-AF)
Acronym: BRAIN-AF
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Consensus BRAIN-AF Executive Steering Committee to terminate.
Enrollment: 1238.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-03-31
Primary completion date: 2024-05-18
Completion date: 2024-05-18
Clinical trial NCT05044325: A First Time in Human (FTIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK3884464 in Healthy Participants
Official title: A Two-Part First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Oral Doses of GSK3884464 in a Randomized, Double Blind, Placebo-Controlled, Dose Escalation Study in Healthy Participants
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: To allow for additional assessments from supplementary non-clinical activities.
Enrollment: 27.0 (ACTUAL)
Number of arms: 10.0
Start date: 2021-09-20
Primary completion date: 2022-08-05
Completion date: 2022-08-05
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, a key secondary endpoints and safety data 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 NCT04433546: Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
Official title: A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (PB1046), a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)
Acronym: VANGARD
Sponsor: PhaseBio Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company no longer pursing indication
Enrollment: 54.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-15
Primary completion date: 2020-12-02
Completion date: 2020-12-02
Clinical trial NCT02908672: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma
Official title: A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 514.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-13
Primary completion date: 2019-10-11
Completion date: 2024-07-01
Clinical trial NCT05020665: Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia
Sponsor: Kronos Bio (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Termination was due to significant challenges associated with study enrollment in a genetic subset of fit participants in the front-line acute myeloid leukemia (AML) setting and other challenges associated with post-COVID impacts.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-24
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Limitations and caveats: Early termination was due to significant unforeseen challenges associated with global enrollment of participants with genetically-defined, newly diagnosed, AML who are candidates for intensive induction therapy and other challenges associated with post-COVID impacts.
Plan to share individual participant data: NO
Clinical trial NCT04532554: Growth Hormone in Obese Cases With Covid-19
Official title: The Impact of Growth Hormone in Obese Cases With Covid-19
Sponsor: ClinAmygate (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-26
Primary completion date: 2020-12-10
Completion date: 2020-12-20
Plan to share individual participant data: NO
Clinical trial NCT03167957: Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
Official title: A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
Sponsor: Matinas BioPharma Nanotechnologies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No longer target indication
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT04962230: Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir
Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF PF-07321332 BOOSTED WITH RITONAVIR IN HEALTHY PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-15
Primary completion date: 2021-10-09
Completion date: 2021-10-09
Baseline population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04869228: A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
Official title: A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
Sponsor: Suzhou Kintor Pharmaceutical Inc, (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: This decision is made on changing the development strategy of GT0918 to adapt ever-changing COVID-19 pandemic management globally.
Enrollment: 380.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-04
Primary completion date: 2022-09-02
Completion date: 2023-08-02
Clinical trial NCT05244070: A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed.
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-14
Primary completion date: 2023-05-04
Completion date: 2023-05-04
Clinical trial NCT04045730: The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
Official title: A Single Arm Phase 2 Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Halozyme isn't allowing this trial to move forward until their current clinical trial results are released.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-15
Primary completion date: 2019-12-31
Completion date: 2021-07-31
Clinical trial NCT04267939: ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer
Official title: An Open-label Phase 1b Study to Determine the Maximum Tolerated and/or Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib (BAY 1895344) in Combination With PARP Inhibitor Niraparib, in Participants With Recurrent Advanced Solid Tumors and Ovarian Cancer
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: There was no anticipated benefit of the experimental combination as tested over available standard therapies; therefore Sponsor has decided to terminate the investigation.
Enrollment: 14.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-02-26
Primary completion date: 2023-12-01
Completion date: 2023-12-01
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT04200989: Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy
Official title: Intra-lymphatic Immunotherapy for the Management of Peanut Allergy
Sponsor: Scripps Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-01
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT02590601: Bromocriptine in the Treatment of Peripartum Cardiomyopathy
Official title: Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial
Acronym: BRO-HF
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Not enough patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-01
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Clinical trial NCT04856007: A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.
Official title: A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-12
Primary completion date: 2021-06-14
Completion date: 2021-06-14
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.
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 deidentified individual patient-level data in an approved sponsored 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 NCT04557475: Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction
Official title: A Randomized Trial of Transplacental Aspirin Therapy for Early Onset Fetal Growth
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: We are modifying this trial's protocol and will resubmit a new application at a later date.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-11
Primary completion date: 2023-06-11
Completion date: 2023-06-11
Plan to share individual participant data: NO