chufangao/CTO huggingface dataset:
Clinical trial NCT05654870: Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia
Sponsor: Neurocrine Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study ATS3020 was closed due to business reasons. Neurocrine Biosciences will continue to conduct study ATS3019 (NCT05110157). There were no unexpected safety findings for this compound that motivated the decision.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-05
Primary completion date: 2023-11-08
Completion date: 2023-11-08
Plan to share individual participant data: NO
Clinical trial NCT04070313: A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
Official title: A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
Sponsor: TTY Biopharm (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study treatment is to use TS-1 (mono-chemotherapy agent) in adjuvant setting for pancreatic cancer, which may be less clinical benefit compared to combination therapy according to current trend at investigators' discretion.
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-11
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Clinical trial NCT00488605: H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis
Official title: H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis
Sponsor: University of New Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: This is a duplicate record and the sponsor has registered the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-08-01
Primary completion date: 2023-08-01
Completion date: 2023-08-01
Clinical trial NCT01626833: Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone
Official title: Severe Decrease of Growth Velocity in Children With Anorexia Nervosa. Therapeutic Trial of Growth Hormone
Acronym: OREX
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-03-31
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Clinical trial NCT03928743: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Acronym: BE MOBILE 2
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 332.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-25
Primary completion date: 2021-09-03
Completion date: 2022-08-08
Baseline population: Baseline Characteristics refer to the Safety Set which consisted of all randomized study participants who received at least one dose of the investigational medicinal product (IMP).
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 NCT02913131: Hyperpolarized C-13 Pyruvate as a Biomarker in Patients With Advanced Solid Tumor Malignancies
Official title: Hyperpolarized C-13 Pyruvate as a Biomarker of PI3K/mTOR Pathway Inhibition in Patients With Advanced Solid Tumor Malignancies
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low Accrual
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-20
Primary completion date: 2021-04-05
Completion date: 2021-04-05
Baseline population: Two of the five participants enrolled in Part B were previously enrolled in Part A.
Limitations and caveats: The study was closed earlier than expected due to low enrollment in both cohorts.
Plan to share individual participant data: NO
Clinical trial NCT04508842: CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
Official title: The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
Sponsor: Hebei Yanda Ludaopei Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Adjustment plan
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-10
Primary completion date: 2022-05-01
Completion date: 2022-05-01
Clinical trial NCT04371406: Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients
Official title: Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients: Randomized Controlled Trial: MG-COVID
Acronym: MG-COVID
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Regulatory approvals have not been obtained
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2020-08-31
Completion date: 2020-09-30
Plan to share individual participant data: YES
IPD sharing description: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.~Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
IPD time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
IPD access criteria: Researchers who provide a methodological sound proposal.
Clinical trial NCT04652479: Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Official title: A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-21
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Baseline population: Participants with no major protocol deviations who were allocated to treatment.
Plan to share individual participant data: NO
Clinical trial NCT05073458: Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
Acronym: PATHWAY
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-15
Primary completion date: 2023-10-17
Completion date: 2024-04-29
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement
Clinical trial NCT03352414: Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
Official title: The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Acronym: ILEUS
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: stopped by sponsor
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-08
Primary completion date: 2020-04-28
Completion date: 2020-04-28
Plan to share individual participant data: NO
IPD sharing description: Study was terminated early
Clinical trial NCT04237792: Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Official title: A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ≥1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 128.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-18
Primary completion date: 2021-11-02
Completion date: 2021-11-30
Baseline population: Full analysis set (FAS) included all randomized participants who received any amount of DEX.
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 NCT03463889: Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
Official title: Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-19
Primary completion date: 2020-09-30
Completion date: 2020-10-31
Limitations and caveats: Study closed earlier than expected due to lack of funding. Due to the small sample size, comparative sub-group analyses could not be performed.
Plan to share individual participant data: NO
Clinical trial NCT04351243: A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Official title: A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Sponsor: Kinevant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 227.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-15
Primary completion date: 2020-12-01
Completion date: 2021-04-01
Limitations and caveats: The Sponsor stopped enrollment of subjects prior to achieving the planned sample size of 270. At the completion of study enrollment, 227 subjects were randomized and 225 received at least one dose of gimsilumab or placebo. All randomized subjects (227 subjects), where possible, completed all study-related activities and had data collected through the planned Day 43 and Day 169 analyses. No safety findings were observed which warranted study termination.
Plan to share individual participant data: NO
Clinical trial NCT05179772: Olanzapine in OUD Patients
Official title: Olanzapine Augmentation of Buprenorphine-naloxone Treatment in OUD Patients With Comorbid Symptoms of Serious Mental Illness (SMI): A Prospective Open-label Single-arm 9-week Study
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: NIDA has advised us to terminate this protocol due to the difficulties in finding appropriate subjects.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-28
Primary completion date: 2023-01-30
Completion date: 2023-01-30
Clinical trial NCT04328467: Pre-exposure Prophylaxis for SARS-Coronavirus-2
Official title: Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Sponsor: University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1483.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-06
Primary completion date: 2020-07-13
Completion date: 2020-07-13
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02932475: Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Official title: Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
Acronym: MOMPOD
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recommendation by the DSMB that the study be stopped for futility
Enrollment: 831.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-25
Primary completion date: 2022-06-15
Completion date: 2022-06-15
Plan to share individual participant data: YES
Clinical trial NCT02769130: Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis
Official title: Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients
Sponsor: The Hospital for Sick Children (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporary suspension
Enrollment: 40.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2016-05-31
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: NO
Clinical trial NCT04470089: A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray
Official title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Dose-finding Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis Such as Throat Soreness Pain and Difficulty to Swallow by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray
Acronym: MIRA1
Sponsor: Megainpharm GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the COVID situation by end of 2021 and therfore limited recruitment of patients diagnosis acute pharyngitis the study was terminated.
Enrollment: 170.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-18
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT04543188: A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
Official title: A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF 07284890 (ARRY 461) IN PARTICIPANTS WITH BRAF V600 MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Pfizer has made an internal business decision to not continue further development of PF-07284890. This decision was not due to major safety concerns or requests from any regulatory authorities.
Enrollment: 66.0 (ACTUAL)
Number of arms: 9.0
Start date: 2021-01-08
Primary completion date: 2024-03-20
Completion date: 2024-03-20
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 NCT04392648: A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Official title: A Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business Decision (no enrollment)
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-06-24
Primary completion date: 2023-11-10
Completion date: 2023-11-10
Plan to share individual participant data: YES
IPD sharing description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Clinical trial NCT03970733: Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
Official title: ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 246.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-01
Primary completion date: 2020-04-07
Completion date: 2022-03-28
Baseline population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
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 NCT03301766: Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
Official title: Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
Sponsor: Cook County Health (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Delay for subject recruitment and then not feasible with COVID\>
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-10
Primary completion date: 2023-05-22
Completion date: 2023-05-22
Plan to share individual participant data: NO
Clinical trial NCT05138549: Astaxanthin for Management of Inflammation in Knee Osteoarthritis
Official title: Effect of Astaxanthin for Pain, Function, and Inflammation in Patients With Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery
Sponsor: Prisma Health-Midlands (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: There are not enough eligible patients at our institution to complete this study.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-02
Primary completion date: 2023-11-14
Completion date: 2023-11-14
Plan to share individual participant data: NO
Clinical trial NCT04387773: Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Official title: Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-05
Primary completion date: 2022-09-01
Completion date: 2022-09-30
Plan to share individual participant data: YES
IPD sharing description: Individual participants' data will be available (including data dictionary) after de-identification and will include all data collected during the trial. The study protocol, statistical analysis plan, informed consent, clinical study report, and analytic code will all be available 3 months after study publication to 5 years after publication. This data will be shared with anyone providing a methodologically sound proposal. To gain access to the data proposals should be directed to carlsonp@ohsu.edu and requesters will need to sign a data access agreement.
IPD time frame: 3 months to 5 years after study publication
IPD access criteria: Requesters will need to sign a data access agreement.