chufangao/CTO huggingface dataset:
Clinical trial NCT04446000: Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of clinical viability
Enrollment: 52.0 (ACTUAL)
Number of arms: 11.0
Start date: 2020-09-23
Primary completion date: 2023-03-28
Completion date: 2023-03-28
Plan to share individual participant data: YES
IPD sharing description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Clinical trial NCT03192215: AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Official title: AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Acronym: ARCADIA
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The DSMB halted the trial prematurely due to futility without any safety concerns.
Enrollment: 1015.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-19
Primary completion date: 2023-03-31
Completion date: 2023-04-17
Plan to share individual participant data: YES
IPD sharing description: To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
IPD time frame: As per NIH/NINDS requirements.
IPD access criteria: All items required by NIH/NINDS will be publicly shared.
Clinical trial NCT04956575: A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults
Official title: A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older
Sponsor: ModernaTX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 885.0 (ACTUAL)
Number of arms: 12.0
Start date: 2021-07-06
Primary completion date: 2022-09-27
Completion date: 2022-09-27
Baseline population: Safety Set: All randomly assigned participants who received the investigational product.
Clinical trial NCT04115293: Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Official title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Acronym: RAISE
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 174.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-17
Primary completion date: 2021-12-30
Completion date: 2021-12-30
Baseline population: The modified Intention-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug and had at least 1 post-dosing MG-ADL score.
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 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.
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 NCT03408483: Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
Official title: Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-01
Primary completion date: 2019-05-10
Completion date: 2020-08-22
Baseline population: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the Quadratus Lumborum Block group for missing data due to early discharge.
Clinical trial NCT03379051: Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Official title: Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Strategic/Business Decision
Enrollment: 78.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-27
Primary completion date: 2022-05-26
Completion date: 2022-06-16
Clinical trial NCT03066115: Impact of NOS, COX, and ROS Inhibition on Cerebral Blood Flow Regulation
Official title: Contributions of Nitric Oxide Synthase, Cyclooxygenase, and Reactive Oxygen Species to Regional Cerebrovascular Control During Hypoxia and Hypercapnia
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: This study was never funded, never fully IRB approved, and thus never enrolled anyone.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-01
Primary completion date: 2021-12-01
Completion date: 2021-12-01
Plan to share individual participant data: NO
Clinical trial NCT05584137: Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC
Official title: A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) in Combination with Serplulimab in Patients with MCRC That Have Received 3 Prior Lines of Therapy
Sponsor: Shanghai Henlius Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to poor clinical trial accrual, the study was terminated.
Enrollment: 2.0 (ACTUAL)
Number of arms: 5.0
Start date: 2023-06-15
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT02122172: Afatinib in Advanced Refractory Urothelial Cancer
Official title: Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unable to meet accrual goal after several years
Enrollment: 95.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-13
Primary completion date: 2024-04-04
Completion date: 2024-04-04
Clinical trial NCT04616586: SILtuximab in Viral ARds (SILVAR) Study
Official title: A Study Comparing the Efficacy and Safety of Standard of Care With or Without Siltuximab in Selected Hospitalized Patients With Viral Acute Respiratory Distress Syndrome (SILVAR)
Acronym: SILVAR
Sponsor: EusaPharma (UK) Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The REMAP-CAP and RECOVERY substudy results appear to support the survival benefit of tocilizumab in corticosteroid-treated or untreated patients with critically ill COVID-19-associated ARDS.
Enrollment: 555.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-13
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Plan to share individual participant data: NO
Clinical trial NCT03128411: Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official title: A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-15
Primary completion date: 2019-03-12
Completion date: 2021-03-04
Baseline population: As-treated population included all enrolled participants who received at least 1 dose of study treatment.
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 NCT04092582: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Official title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 135.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2022-05-19
Completion date: 2022-05-19
Baseline population: Modified Intent-to-Treat population (mITT) population included all randomized participants who received at least one dose of study treatment.
Limitations and caveats: Enrollment was halted on 08 April 2020 in response to the emerging pandemic and concerns regarding data integrity (e.g., missed study doses and visits). The trial was restarted on 22 June 2020.
Plan to share individual participant data: YES
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 NCT03153111: A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Official title: A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Acronym: SERENADE
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 143.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-11
Primary completion date: 2021-03-12
Completion date: 2021-03-12
Baseline population: Baseline analysis population includes full analysis set (FAS) which included participants randomized to double-blind study treatment.
Limitations and caveats: Recruitment was stopped prematurely in December 2019 due to slow enrollment which resulted in an underpowered study and impacted the meaningful interpretation of the results.
Plan to share individual participant data: NO
Clinical trial NCT02332577: Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
Official title: A Multi-centre, Non-inferiority, Randomized, Double-blind, Phase IV Study Comparing Pristinamycin (2g x 2 Per Day for 2 Days Then 1g x 3 Per Day for 5 to 7 Days) to Amoxicillin (1g x 3 Per Day) for 7 to 9 Days in Adults With Acute Community Acquired Pneumonia With a PORT Score of II or III
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The sponsor stopped the study due to low recruitment with no safety concerns
Enrollment: 161.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-30
Primary completion date: 2023-02-20
Completion date: 2023-02-20
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 NCT04207710: Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
Official title: Study to Determine the Safety of Gebauer's Ethyl Chloride and Gebauer's Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-01-26
Primary completion date: 2022-02-25
Completion date: 2022-02-25
Plan to share individual participant data: NO
Clinical trial NCT04456608: Genetic and Dietary Predictors of Anti-platelet Response
Official title: Program on Genetic and Dietary Predictors of Drug Response in Rural and AI/AN Populations, Project-3, SA-3, Anti-platelet Response
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Funding ended before the study could be completed,
Enrollment: 126.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-01
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Clinical trial NCT03085394: Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Official title: Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Acronym: PHORBBS
Sponsor: Sheba Medical Center (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Enrollment stopped, patients refuse to participate.
Enrollment: 152.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-01
Primary completion date: 2022-11-21
Completion date: 2022-11-21
Clinical trial NCT03950674: Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study
Official title: A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-22
Primary completion date: 2019-05-20
Completion date: 2023-06-22
Baseline population: The Baseline Analysis Population consisted of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03797443: High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer
Official title: Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Had No Prior Therapy for Their Metastatic Pancreatic Cancer
Sponsor: Piedmont Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Regulatory Review needed
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-01
Primary completion date: 2022-01-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04800822: PF-07284892 in Participants With Advanced Solid Tumors
Official title: A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EVIDENCE OF ANTI-TUMOR ACTIVITY OF PF-07284892 (ARRY-558) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was prematurely discontinued due to strategic reasons, not major safety concerns, futility, or requests from any regulatory authorities
Enrollment: 53.0 (ACTUAL)
Number of arms: 9.0
Start date: 2021-03-17
Primary completion date: 2024-06-19
Completion date: 2024-06-19
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 NCT02564796: Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic CHD - A Prospective Control Trial
Official title: Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Limitations and caveats: The principal investigator discussed the study's future with the sub-investigators on the study and came to the conclusion to terminate the study early due to low enrollment while also considering the financial costs to continue to run the study. It would be highly improbable to be able to enroll 54 more patients with the amount of funding left in the grant. No subjects were analyzed.
Plan to share individual participant data: NO
Clinical trial NCT04330625: Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)
Official title: A Pilot Study of Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (GRIP-IT PILOT)
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-13
Primary completion date: 2021-05-05
Completion date: 2021-05-05
Plan to share individual participant data: NO
Clinical trial NCT01784159: ASpirin for Patients With SEPsis and SeptIc Shock
Official title: Impact of Aspirin Use on the Severity of Organ Dysfunctions in Patients With Sepsis and Septic Shock: a Randomized, Double-blind, Placebo-controlled Trial - ASP-SEPSIS.
Acronym: ASP-SEPSIS
Sponsor: Federal University of São Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated: The study was stopped prematurely and will not be resumed due to the higher number of bleeding cases in the intervention group, as recomended by the Data Safety Monitoring Board on February 7, 2023.
Enrollment: 167.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-27
Primary completion date: 2022-12-15
Completion date: 2023-01-05
Plan to share individual participant data: UNDECIDED
IPD sharing description: undecided
Clinical trial NCT03725852: A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis
Acronym: PINTA
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-27
Primary completion date: 2020-07-21
Completion date: 2020-08-14
Baseline population: Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Limitations and caveats: The study was not powered to detect statistical significance and was limited by its small sample size, high variability of the primary endpoint (FVC), and a high rate of early treatment discontinuations.
Plan to share individual participant data: NO
Clinical trial NCT01667744: Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Official title: Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: unfunded
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-01
Primary completion date: 2016-02-01
Completion date: 2021-02-16
Plan to share individual participant data: UNDECIDED
IPD sharing description: Study not funded.