chufangao/CTO huggingface dataset:
Clinical trial NCT04393441: Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease
Official title: A Multicenter, Single-masked, Randomized Study to Compare the Efficacy and Safety of a New Artificial Tear Formulation (011516X) With Systane® Ultra Multidose for 90 Days in Participants With Dry Eye Disease
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 400.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-29
Primary completion date: 2021-06-15
Completion date: 2021-06-15
Baseline population: Intend to treat (ITT) population consisted of all randomized participants.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT02901548: Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder
Official title: A Phase 2 Study of Check Point Inhibitor, Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refractory Urothelial Carcinoma in Situ (CIS) of the Bladder
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study closed early due to futility
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-16
Primary completion date: 2020-07-24
Completion date: 2021-09-07
Limitations and caveats: All reported deaths were on post study treatment survival follow up.
Clinical trial NCT03378297: IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC
Official title: IMPACT: A Phase 0 Randomized Window-of-Opportunity Study of Novel and Repurposed Therapeutic Agents in Women Triaged to Primary Surgery for Advanced Epithelial Ovarian Cancer in Stages IIIa - IV.
Acronym: IMPACT
Sponsor: Haukeland University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-05-04
Primary completion date: 2023-01-05
Completion date: 2023-01-05
Plan to share individual participant data: NO
Clinical trial NCT02954458: Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Official title: A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-09
Primary completion date: 2020-11-05
Completion date: 2020-11-05
Baseline population: The safety population consisted of enrolled participants who provided informed consent and met all the inclusion criteria.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT02069431: Oxytocin Aging Study
Official title: Effects of Oxytocin on Physical and Cognitive Functioning in the Elders
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was halted prematurely due to the COVID-19 pandemic, resulting in the inability to enroll participants. Funding for this project has also ended.
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Clinical trial NCT05083949: A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together
Official title: Relative Bioavailability of Empagliflozin/Metformin Fixed-dose Combination - Empagliflozin 12.5 mg + Metformin 850mg (Boehringer Ingelheim) Coated Tablet Versus Jardiance® 10mg (Reference 1: Boehringer Ingelheim) Coated Tablet and Glifage® 850mg (Reference 2: Merck S / A. ) Coated Tablet, Administered Together in Healthy Male and Female Subjects Under Fed Conditions: an Open-label, Randomised, Single-dose, Two-way Crossover Study
Acronym: InPedILD®
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-23
Primary completion date: 2021-08-06
Completion date: 2021-09-09
Baseline population: Treated Set (TS): The treated set included all participants in the research that were randomized and treated with at least one dose of study medication.
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:https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT01265017: Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes
Official title: Single-center, Double-masked, Placebo-controlled Parallel-group Study of Pregnancy-related Hormones Estradiol and Medroxyprogesterone, in Conjunction With Hydrocortisone and Growth Hormone to Stimulate C-peptide Secretion in Women With T1DM
Sponsor: Sansum Diabetes Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Insufficient funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-07-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT03790072: Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)
Official title: Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune®) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study
Sponsor: TC Biopharm (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-27
Primary completion date: 2021-03-26
Completion date: 2021-03-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04581785: Gene Therapy With hLB-001 in Pediatric Patients With Severe Methylmalonic Acidemia
Official title: A Phase 1/2 Open-label Clinical Study of hLB-001 Gene Therapy in Pediatric Patients With Methylmalonic Acidemia Characterized by MMUT Mutations
Acronym: SUNRISE
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to low likelihood of clinical benefit in treated participants.
Enrollment: 4.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-05-29
Primary completion date: 2023-01-10
Completion date: 2023-01-10
Baseline population: The safety population included all participants who received at least 1 dose of study drug. Cohorts have been combined in the Baseline Characteristics section to maintain participant confidentiality.
Limitations and caveats: The study was terminated early due to low likelihood of clinical benefit in treated participants. Hence; no participants were enrolled in Part C and thus Cohort 2 was not initiated.
Plan to share individual participant data: NO
Clinical trial NCT03856359: Trial of Rifaximin in Probable Alzheimer's Disease
Official title: Pilot, Single Center, Open, Trial of Rifaximin in Probable Alzheimer's Disease
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-09
Primary completion date: 2020-11-19
Completion date: 2020-11-19
Plan to share individual participant data: NO
Clinical trial NCT04067492: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack
Official title: An Open-label, Single-dose, Active-controlled Randomized Phase IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 (RPH-104/L04018) Administered at Different Doses to Patients With Acute Gout Attack
Sponsor: R-Pharm (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: In view of the continuing insufficient patient recruitment in the study due to the difficult epidemiological situation and the need for rational allocation of company resources, as well as based on the results of the interim analysis.
Enrollment: 47.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-03-26
Primary completion date: 2020-03-16
Completion date: 2020-05-12
Clinical trial NCT04918147: Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
Official title: Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated early based on disease flare/lack of efficacy in the early phase of the trial.
Enrollment: 8.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-13
Primary completion date: 2024-01-04
Completion date: 2024-01-04
Plan to share individual participant data: YES
IPD sharing description: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
IPD time frame: On average, within 24 months after database lock for the trial.
IPD access criteria: Open access.
Clinical trial NCT04498468: Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
Official title: Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.
Enrollment: 77.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-16
Primary completion date: 2023-03-03
Completion date: 2023-03-03
Baseline population: Only 75 (150 eyes) patients' data were analyzed at baseline as 2 patients were lost to follow-up before week 4.
Limitations and caveats: The study was not able to enroll its planned sample size. VAS, while consistently used in measuring clinical symptoms of illnesses, is limited in that patients may encounter difficulties in rating their symptomology, especially if the participants feel ambivalent towards the VAS prompts.
Plan to share individual participant data: NO
IPD sharing description: Aggregated information only will be shared with sponsor
Clinical trial NCT03767439: Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome
Official title: Trial of Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome (BCNS)
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Loss of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-31
Primary completion date: 2019-12-31
Completion date: 2020-02-29
Clinical trial NCT01345578: Hepatocyte Transplantation for Liver Based Metabolic Disorders
Official title: Hepatocyte Transplantation for Liver Based Metabolic Disorders
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: seeking additional funding
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-03-31
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03058094: A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI
Official title: A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI
Sponsor: Hangzhou ACEA Pharmaceutical Research Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Considiering to change the Chemotherapy into Gefitinib
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-31
Primary completion date: 2019-12-31
Completion date: 2020-01-31
Plan to share individual participant data: NO
Clinical trial NCT03490760: Durvalumab and Booster Radiation in Metastatic Adenocarcinoma of the Pancreas
Official title: Phase II Trial of In Situ Tumor Vaccination Using Durvalumab and Booster Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy
Sponsor: Baptist Health South Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow/poor enrollment
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-09
Primary completion date: 2020-07-09
Completion date: 2020-07-09
Limitations and caveats: This study was terminated early because of poor enrollment and participants being withdrawn soon after enrollment due to disease progression. Statistical analysis was not possible with the small number of evaluable participants.
Plan to share individual participant data: NO
Clinical trial NCT03212352: Comparing Two Medical Treatments for Early Pregnancy Failure.
Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
Acronym: Triple M
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Advised by DSMB based on interim-analysis, highly significant difference.
Enrollment: 342.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-27
Primary completion date: 2020-01-23
Completion date: 2020-03-16
Plan to share individual participant data: NO
Clinical trial NCT04143581: SGLT2 Inhibitors in Glomerular Hyperfiltration
Official title: Evaluating the Short-Term Renal and Systemic Effects of SGLT2 Inhibition in Non-Diabetic Patients at Risk of Accelerated GFR Decline Because of Glomerular Hyperfiltration: a Sequential OFF-ON-OFF Study With One-Month Empagliflozin Therapy Followed by One-Month Recovery Period
Acronym: EMPATHY
Sponsor: Mario Negri Institute for Pharmacological Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funds
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-03
Primary completion date: 2021-09-03
Completion date: 2021-09-03
Plan to share individual participant data: NO
Clinical trial NCT04032717: Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)
Official title: A Randomized, Double-Blind Phase 1 Safety and Pharmacokinetic Study of Q-Griffithsin Enema Administered Rectally to HIV-1 Seronegative Adults
Acronym: PREVENT
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.
Enrollment: 18.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-10
Primary completion date: 2021-02-04
Completion date: 2021-02-04
Plan to share individual participant data: YES
IPD sharing description: The awardee institution will follow Federal grant policies concerning the sharing of research data. The awardee institution will share its information, data and resources among its own researchers and the collaborating researchers as well as with researchers at other institutions. The research team will make the results of this collaboration and any accompanying data available to the public. In accordance with Federal policies on Data Sharing, research data will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. Also, all human subjects' rights to privacy with respect to any human tissue samples to be used as a part of this study will be approved by the appropriate regulatory boards, protected and de-identified.
IPD time frame: Upon publication
Clinical trial NCT01711658: TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
Official title: TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
Acronym: TRYHARD
Sponsor: Radiation Therapy Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 142.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-03-15
Primary completion date: 2020-12-01
Completion date: 2022-09-21
Baseline population: All randomized patients
Limitations and caveats: A total of 69 progression-free survival (PFS) were required. As of September 13, 2020, the number of observed PFS events was 66. At the Radiation Therapy Oncology Group Foundation Data Monitoring Committee meeting on October 22, 2020, a decision was made to report the final results using data through November 30, 2020. This decision has a minor impact (\<1%) on the power given that 67 PFS events are included in the final analysis of this trial.
Clinical trial NCT03265288: Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults
Official title: APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults
Acronym: APPLAUD
Sponsor: Laurent Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 166.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-05
Primary completion date: 2021-09-15
Completion date: 2021-09-15
Limitations and caveats: The APPLAUD study started enrollment in November 2018 and was conducted through the COVID-19 pandemic and during market introduction of ETI (elexacaftor/tezacaftor/ivacaftor) in the participating countries. However, the study protocol and the statistical plan were amended to address the higher dropout rates caused by these two factors during the clinical trial and to allow enrolment of patients stabilized on ETI as their background CFTR modulator therapy.
Plan to share individual participant data: NO
Clinical trial NCT03148795: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
Official title: TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 128.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-04
Primary completion date: 2020-09-04
Completion date: 2023-03-31
Baseline population: Safety population included all participants who received at least 1 dose of talazoparib including participants enrolled prior to protocol amendment 3 with non-measurable disease and with deoxyribonucleic acid damage response (DDR) deficiencies which was likely or might sensitized the tumor to poly adenosine diphosphate-ribose polymerase (PARP) inhibition as assessed using an expanded DDR gene panel.
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 NCT04893018: NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
Official title: Phase 1 Study of NT-I7 (rhIL-7-hyFc) for the Treatment of Kaposi Sarcoma in Patients With or Without Infection With HIV
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated due to end of funding
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-23
Primary completion date: 2023-12-15
Completion date: 2023-12-15
Baseline population: Population included all enrolled participants.
Limitations and caveats: Enrollment for this study was terminated early due end of funding. Some of the planned statistical analyses were not performed.
Plan to share individual participant data: NO
Clinical trial NCT04350450: Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore
Official title: Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI withdrew the submission to the IRB
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO