chufangao/CTO huggingface dataset:
Clinical trial NCT04900428: Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated at interim analysis due to drops not working on new variants
Enrollment: 179.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-16
Primary completion date: 2022-03-22
Completion date: 2022-05-06
Clinical trial NCT03591874: Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Acronym: oGVHD
Sponsor: Ocugen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Primary endpoint was not met.
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-23
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Baseline population: The safety set includes all participants who signed informed consent forms, were randomized into the study, and took at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: There is no current plan to share participant data with other researchers.
IPD time frame: A clinical Study Report will be submitted once the study data has been analyzed.
Clinical trial NCT04252742: Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
Official title: Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study
Acronym: EMBRACE
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 512.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2023-10-26
Completion date: 2023-10-26
Baseline population: The full analysis set included all participants who were randomized in the study.
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT04274907: A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression
Official title: A Phase 1b Study of Venetoclax in Combination With Pembrolizumab in Subjects With Previously Untreated NSCLC Whose Tumors Have High PD-L1 Expression
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Company Decision
Enrollment: 2.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-30
Primary completion date: 2021-02-02
Completion date: 2021-02-02
Plan to share individual participant data: NO
Clinical trial NCT03026023: Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
Official title: A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-01
Primary completion date: 2020-12-31
Completion date: 2021-06-30
Plan to share individual participant data: YES
IPD sharing description: Deidentified patient data will be shared with research collaborators for safety and data analysis.
Clinical trial NCT05355753: A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
Official title: A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
Sponsor: C4 Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.
Enrollment: 50.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-03-25
Primary completion date: 2023-12-19
Completion date: 2023-12-19
Plan to share individual participant data: NO
Clinical trial NCT03574597: Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
Official title: SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Acronym: SELECT
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 17604.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-24
Primary completion date: 2023-06-21
Completion date: 2023-06-29
Baseline population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04912427: Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
Official title: A Phase Ib Study of Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-04-01
Primary completion date: 2022-12-06
Completion date: 2024-01-26
Plan to share individual participant data: NO
Clinical trial NCT05005507: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
Official title: A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection
Acronym: PENGUIN-2
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A strategic decision was made to not further execute the study. This decision was not based on a safety concern.
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-03
Primary completion date: 2021-12-29
Completion date: 2021-12-29
Limitations and caveats: Only 1 participant was enrolled in the study in Arm 1. Participants were also planned to be enrolled in Arms 2 and 3 but were not enrolled as the study terminated prematurely based on a strategic decision and not for safety reasons.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
Clinical trial NCT06065059: Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
Official title: Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG348 Single Agent and in Combination With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or Other HRD+ Solid Tumors
Sponsor: Tango Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated due to safety
Enrollment: 7.0 (ACTUAL)
Number of arms: 8.0
Start date: 2023-12-08
Primary completion date: 2024-05-22
Completion date: 2024-05-22
Plan to share individual participant data: NO
Clinical trial NCT04688671: Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects With Diabetic Peripheral Neuropathic Pain
Sponsor: Eliem Therapeutics (UK) Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 167.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-09
Primary completion date: 2022-02-09
Completion date: 2022-02-18
Plan to share individual participant data: NO
Clinical trial NCT04444167: A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma
Official title: An Open-Label Multi-Center Phase Ib/II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in Combination With Lenvatinib As the First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma
Sponsor: Akeso (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 59.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-07
Primary completion date: 2023-11-20
Completion date: 2023-11-20
Clinical trial NCT02816736: EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)
Official title: EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)
Acronym: HFN-LIFE
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 365.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-02
Primary completion date: 2020-09-15
Completion date: 2020-09-29
Plan to share individual participant data: NO
Clinical trial NCT05148442: A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
Official title: A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the company's development strategy adjustment\]
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-28
Primary completion date: 2023-06-19
Completion date: 2023-08-29
Plan to share individual participant data: NO
Clinical trial NCT03553576: Drug Concentration and Volume on Adequate Labor Analgesia With PIEB
Official title: The Relationship Between Local Anesthetic Concentration and Volume on Adequate Labor Analgesia With Programmed Intermittent Epidural Bolus
Acronym: CADD2
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of continued funding
Enrollment: 156.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-09
Primary completion date: 2023-05-31
Completion date: 2023-06-01
Clinical trial NCT04560010: TXA in Anticoagulated Patients Study
Official title: The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Enrollment rate was slower than anticipated
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-06
Primary completion date: 2023-03-11
Completion date: 2023-03-11
Plan to share individual participant data: YES
IPD sharing description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: 9 months and ending 36 months following article publication
IPD access criteria: Requests may be directed to the PI.
Clinical trial NCT04276415: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)
Official title: Phase 1, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Subjects With Advanced Gastrointestinal Stromal Tumor
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to a business decision.
Enrollment: 34.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-08
Primary completion date: 2022-03-11
Completion date: 2022-03-11
Baseline population: Demographic and baseline characteristics were assessed in the Safety Analysis Set.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT04129489: A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis
Official title: A Phase 2a Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis
Sponsor: Stero Biotechs Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-07
Primary completion date: 2020-03-01
Completion date: 2020-03-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04735510: Novel Use of Restasis and PROSE Devices
Official title: Novel Use of Restasis (Cyclosporine Ophthalmic Emulsion 0.05%) on Application of PROSE Devices for Management of Patients With Ocular Surface Disease: A Pilot Study
Sponsor: Boston Sight (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: study redesigned
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-31
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share IPD
Clinical trial NCT04001036: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
Official title: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Sponsor: Iperboreal Pharma Srl (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-01
Primary completion date: 2022-08-30
Completion date: 2022-08-30
Clinical trial NCT03722589: Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP
Official title: Randomized Open-Label Trial to Compare the Immunogenicity of Cell Culture-Based and Recombinant Unadjuvanted Quadrivalent Influenza Vaccines to Conventional Egg-Based Unadjuvanted Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years
Sponsor: Centers for Disease Control and Prevention (FED)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 944.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-09-12
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Baseline population: Baseline characteristics are presented for Year 1 participants. There were no Fluzone High-Dose participants enrolled in year 1.
Plan to share individual participant data: YES
IPD sharing description: IPD will be made available to contractor and site research staff. This data can be made available to other researchers upon request.
IPD time frame: Study period
Clinical trial NCT03123744: Histology-Independent Study of Palbociclib in Patients With Advanced Cancer
Official title: A Histology-Independent Study of the Cyclin Inhibitor Palbociclib in Patients With Advanced Cancer Harboring Aberrations in the Cyclin Pathway
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No study funding available.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-01
Primary completion date: 2020-02-01
Completion date: 2024-02-01
Plan to share individual participant data: NO
Clinical trial NCT03100877: Melphalan, Total Marrow Irradiation, and Autologous Stem Cell Transplantation in Treating Patients With High-Risk Multiple Myeloma
Official title: Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Feasibility Issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-31
Primary completion date: 2020-05-24
Completion date: 2020-05-24
Clinical trial NCT05422001: Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
Official title: Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
Acronym: KetMo
Sponsor: University of Aarhus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Not able to recruit opioid tolerant patients as expected
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-31
Primary completion date: 2023-08-15
Completion date: 2023-08-15
Plan to share individual participant data: YES
IPD sharing description: Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing
Clinical trial NCT03867240: Gabapentin and Chronic Post Surgical Pain
Official title: The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
Acronym: CPSP
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study initially suspended recruitment due to COVID-19. Study withdrawn due to PI leaving institution in early 2021.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results after de-identification (text, tables, figures and appendices) will be shared. The following related documents will be available: study protocol, statistical analysis plan, analytic code. Data will become available immediately following publication and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis. Request for proposal should be directed to Cheryl.maenpaa@emory.edu.To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
IPD time frame: Data will become available immediately following publication and ending 5 years following article publication.
IPD access criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis.
Clinical trial NCT03103087: LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official title: LIBERTY 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Sponsor: Myovant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 382.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-06-14
Primary completion date: 2019-07-10
Completion date: 2020-09-16
Baseline population: All participants who were enrolled and randomized in the study.
Limitations and caveats: None reported
Plan to share individual participant data: NO