chufangao/CTO huggingface dataset:
Clinical trial NCT04333147: Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Official title: A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
Acronym: contRAst X
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study is early terminated due to Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.
Enrollment: 2916.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-12
Primary completion date: 2023-02-24
Completion date: 2023-02-24
Baseline population: One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=1459).
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, 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 NCT01828099: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
Official title: A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 376.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-07-09
Primary completion date: 2016-06-24
Completion date: 2024-01-07
Baseline population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.
Limitations and caveats: Among the 187 patients randomized to chemotherapy arm, 12 patients were not treated.
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 NCT02573324: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Official title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Acronym: Intellance1
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 691.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-01-04
Primary completion date: 2022-04-04
Completion date: 2022-04-04
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 NCT04505878: Perioperative Vitamin C Lung Transplant
Official title: Vitamin C: Assessing Safety After Lung Transplant
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Decided not to proceed with study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-04-30
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting Dr. Micah Long, the Principal Investigator of this study.
IPD time frame: up to 7 years after the completion of the primary endpoint
Clinical trial NCT04934670: A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients With Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
Acronym: 2002
Sponsor: Xenikos (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib arms
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-16
Primary completion date: 2022-11-10
Completion date: 2023-01-19
Baseline population: A sample size of 246 participants was planned for this study with a 24-participant safety run-in. However, the study was stopped early after enrollment of 12 participants. Of these participants, 7 were randomized to T-Guard and 5 to ruxolitinib treatment.
Limitations and caveats: Early termination leading to small numbers of subjects analyzed, which resulted in the preparation and submission to the FDA and European authorities of an abbreviated clinical study report that did not contain all the outcome measures as specified in the clinical protocol.
Plan to share individual participant data: NO
Clinical trial NCT05063734: A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
Official title: A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
Acronym: INTEGRAL
Sponsor: Oxurion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B.
Enrollment: 16.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-08-27
Primary completion date: 2022-06-29
Completion date: 2022-06-29
Limitations and caveats: Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B
Plan to share individual participant data: NO
Clinical trial NCT00497926: Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Official title: Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Sponsor: Talaris Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: living donor kidney program terminated due to slow pace of phase 3 study enrollment
Enrollment: 37.0 (ACTUAL)
Number of arms: 1.0
Start date: 2008-03-31
Primary completion date: 2023-03-31
Completion date: 2023-04-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02606136: Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
Official title: Trial of Pamrevlumab (FG-3019), a Monoclonal Antibody to Connective Tissue Growth Factor, in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy
Acronym: MISSION
Sponsor: FibroGen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-04
Primary completion date: 2020-05-07
Completion date: 2023-08-09
Baseline population: Intent-to-treat (ITT) population included all participants who enrolled in the study.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03138512: A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
Official title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Acronym: CheckMate 914
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1653.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-07-07
Primary completion date: 2023-09-12
Completion date: 2024-02-01
Plan to share individual participant data: NO
Clinical trial NCT03399448: NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
Official title: Phase 1 Trial of Autologous T Cells Engineered to Express NY-ESO-1 TCR and CRISPR Gene Edited to Eliminate Endogenous TCR and PD-1 (NYCE T Cells)
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor has terminated trial to pursue other targets.
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-05
Primary completion date: 2020-02-29
Completion date: 2020-10-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04158349: Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer
Official title: Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous mFOLFIRI for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer
Acronym: IPOX-FOLFIRI
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: PI Decision
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-03-22
Primary completion date: 2021-05-14
Completion date: 2021-05-14
Plan to share individual participant data: NO
Clinical trial NCT05032521: Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)
Official title: Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)
Acronym: LACTEL
Sponsor: Centre Hospitalier Universitaire Dijon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-02
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Clinical trial NCT02354547: A Study of SGT-53 in Children With Refractory or Recurrent Solid Tumors
Official title: A Phase I Study of SGT-53, a TfRscFv-Liposome-p53 Complex, in Children With Refractory or Recurrent Solid Tumors
Sponsor: SynerGene Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Enrollment: 18.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2014-12-31
Primary completion date: 2022-12-31
Completion date: 2023-12-31
Clinical trial NCT02706847: A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Acronym: SELECT-BEYOND
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 499.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-03-15
Primary completion date: 2017-04-03
Completion date: 2022-02-08
Baseline population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. The 2 placebo groups were combined for analysis of data through Week 12.
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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04820023: Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment
Official title: A Phase 1/2, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BBT-176 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) Agent
Sponsor: Bridge Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision considering the changing treatment landscape for NSCLC
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-02
Primary completion date: 2023-11-29
Completion date: 2023-11-29
Clinical trial NCT05205837: A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
Official title: A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids on Plasma Reproductive Hormones, Fertility, Withdrawal Symptoms and Myocardial Function - The LUCAS Trial
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of recruitment
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-24
Primary completion date: 2023-08-15
Completion date: 2023-08-15
Plan to share individual participant data: NO
Clinical trial NCT04132349: Ulipristal Acetate in Symptomatic Uterine Fibroid
Official title: The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid
Sponsor: Mỹ Đức Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Ulipristal Acetate was recalled
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-23
Primary completion date: 2020-04-01
Completion date: 2020-04-01
Clinical trial NCT02994784: Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients
Official title: A Phase II Single-Center, Open-Label, Safety and Efficacy Study of Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients Undergoing Autologous Stem Cell Transplantation
Sponsor: Boston Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow Accrual during COVID pandemic, alternative treatments available. Study halted early.
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-08
Primary completion date: 2022-07-01
Completion date: 2022-07-01
Limitations and caveats: Study was halted early resulting in relatively small numbers of participants analyzed.
Plan to share individual participant data: NO
IPD sharing description: There are no plans to share individual participant data.
Clinical trial NCT03588611: Reduce Bolus Injection of Bivalirudin
Official title: The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function
Sponsor: Shenyang Northern Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 204.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-01
Primary completion date: 2021-06-26
Completion date: 2021-06-26
Clinical trial NCT02910583: Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Official title: Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Acronym: Captivate
Sponsor: Pharmacyclics LLC. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 323.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-09-28
Primary completion date: 2020-11-12
Completion date: 2024-03-27
Plan to share individual participant data: YES
IPD sharing description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.
Clinical trial NCT04358406: Rhu-pGSN for Severe Covid-19 Pneumonia
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study To Evaluate Efficacy And Safety Of Recombinant Human Plasma Gelsolin (Rhu-pGSN) Added To Standard Of Care In Subjects With Severe Covid-19 Pneumonia
Sponsor: BioAegis Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-30
Primary completion date: 2021-05-25
Completion date: 2022-01-28
Plan to share individual participant data: NO
Clinical trial NCT04468230: Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Official title: Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low Accrual Rate
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-31
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Baseline population: Confidentiality is an issue.
Limitations and caveats: The Coronavirus-19 (COVID-19) pandemic caused reduced accrual rates. The protocol was terminated early due to slow accrual rates by the Protocol Review \& Monitoring Committee (PRMC).
Plan to share individual participant data: NO
Clinical trial NCT03979820: A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure
Official title: A Phase I Parallel Group Study in Healthy Subjects to Evaluate the Effect of Multiple Oral Doses of BI 1467335 and Phenelzine as Positive Control on Blood Pressure Response to Oral Tyramine (Double-blind, Randomised, Placebo-controlled Design for BI 1467335 Treatment Groups, Open Label for Phenelzine)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study discontinued - testing of highest dose obsolete
Enrollment: 53.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-31
Primary completion date: 2020-04-08
Completion date: 2020-04-08
Baseline population: Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. The TS was used for the analysis of safety.
Limitations and caveats: The sponsor decided to permanently discontinue the trial on 14 April 2020 due to lock down of the trial site enforced by the Covid-19 pandemic. Therefore some of the planned analysis were not performed due to lack of data.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/
Clinical trial NCT05611853: Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Official title: A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN301，An Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-cell Non-Hodgkin's Lymphoma
Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to company decision
Enrollment: 9.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-11-25
Primary completion date: 2023-12-25
Completion date: 2023-12-25
Clinical trial NCT04692467: Treatment of Early Hypertension Among Persons Living With HIV in Haiti
Official title: Treatment of Early Hypertension Among Persons Living With HIV in Haiti
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 250.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-26
Primary completion date: 2023-06-30
Completion date: 2023-12-30
Baseline population: In intention-to-treat analysis, the analysis population is the same as the assignment under randomization.
Plan to share individual participant data: YES
IPD sharing description: All the individual participant data collected during the trial, after deidentification will be shared.
IPD time frame: Study protocol and statistical analysis plan available after publication and ending 3 years following publication.
IPD access criteria: Researchers who provide a methodologically sound proposal may have access. Proposals should be directed to the PI at mam9365@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement. Data are available following publications through 3 years after publication and will be provided directly from the PI.