chufangao/CTO huggingface dataset:
Clinical trial NCT04327024: Study of Verinurad in Heart Failure With Preserved Ejection Fraction
Official title: A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad Combined With Allopurinol in Heart Failure With Preserved Ejection Fraction
Acronym: AMETHYST
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-19
Primary completion date: 2022-04-29
Completion date: 2022-04-29
Baseline population: The Full Analysis Set includes all subjects who have been randomized to study treatment.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04324359: Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
Official title: A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects
Sponsor: Surface Ophthalmics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 91.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-03
Primary completion date: 2020-11-03
Completion date: 2020-11-20
Baseline population: Randomized participants who underwent routine uncomplicated cataract surgery.
Clinical trial NCT04318704: Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
Official title: An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
Sponsor: Algernon Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-29
Primary completion date: 2022-05-10
Completion date: 2022-05-10
Plan to share individual participant data: NO
Clinical trial NCT02449161: The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates
Official title: The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT
Acronym: MPA postAE
Sponsor: Université de Sherbrooke (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Missing fund to continue
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Clinical trial NCT04523831: Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection
Official title: A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care
Sponsor: Dhaka Medical College (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 400.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-01
Primary completion date: 2020-08-22
Completion date: 2020-09-10
Baseline population: We followed intention to treat analysis; SPSS (Statistical Package for Social Sciences) version 20 was used to analyze data. To compare mean of the two group chi square test was done.
Limitations and caveats: We followed up the patients by telephonic (video) interview, which has some inherent drawback for the study. we could not assess viral clearance directly. Only single dose regimen was used. Efficacy might higher if the different regimen would use.
Plan to share individual participant data: YES
IPD sharing description: Patients age, sex, Date of covid positive report, Symtoms,Date of covid negative report, post covid symptoms, time to recover.
IPD time frame: September 2020 to December 2020
IPD access criteria: Person who are investigating covid-19 in various aspects
Clinical trial NCT03440814: A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
Sponsor: Soleno Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 127.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-09
Primary completion date: 2020-05-01
Completion date: 2020-05-01
Baseline population: Safety population includes all randomized subjects who receive any amount of study drug.
Limitations and caveats: All subjects were enrolled and had baseline visits prior to the COVID-19 pandemic; however, there was a subset of subjects who needed to complete some of their visits after the onset of the pandemic. The pandemic forced numerous restrictions on normal activities and involved significant disruptions, which had a substantially adverse but inconsistent effect on the study conduct and results. For this reason, the ITT population - Pre-COVID analysis includes all data through March 1, 2020.
Clinical trial NCT02258451: Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
Official title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 283.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-04
Primary completion date: 2020-01-22
Completion date: 2022-10-28
Baseline population: Intent-to-Treat Analysis Set (ITT analysis set): included all randomized participants
Limitations and caveats: Due to reassessment of the Primary Completion date (PCD) conditions, PCD was moved back to 22 January 2020. Interim survival data on patients transferring from this study to study 16996 (NCT02312960), as of analysis cutoff, was pooled with this study's data to increase the reliability of efficacy results. This pooling was specified in a supplemental SAP dated 24 Jun 2020. All other primary and secondary analysis details were specified in the main study SAP dated 14 Feb 2020.
Clinical trial NCT04614298: A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
Official title: A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-31
Primary completion date: 2022-02-28
Completion date: 2022-11-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03262701: Adjunctive Hydrogen Peroxide for Periodontal Therapy
Official title: Custom Tray Application of Peroxide Gel as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis: A 6-Month Randomized Trial
Acronym: AHP
Sponsor: Loma Linda University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: COVID
Enrollment: 42.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-02
Primary completion date: 2021-02-08
Completion date: 2021-02-08
Limitations and caveats: Due to COVID lockdown, the enrollment and study discontinued abruptly.
Clinical trial NCT02546492: Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Official title: Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Acronym: TGActhar
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow Enrollment
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-31
Primary completion date: 2021-05-27
Completion date: 2021-05-27
Limitations and caveats: Only one participant completed the treatment with the study drug Acthar (24 weeks). The other five (5) individuals withdrew from the study early, therefore we are not able to analyze/interpret the efficacy of the study drug.
Clinical trial NCT02517697: Oral Nitrite Trial for Hypertension and Metabolic Syndrome
Official title: Nitrite Modulation of Hypertension, Platelet Activation, and Endothelial and Mitochondrial Function
Acronym: ONPC
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: We will not initiate recruitment for this protocol due to lack of funding to support this placebo-controlled trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-31
Primary completion date: 2021-04-13
Completion date: 2021-04-13
Plan to share individual participant data: NO
Clinical trial NCT03154996: Chronic Convection Enhanced Delivery of Topotecan
Official title: Chronic Convection Enhanced Delivery of Topotecan for Recurrent High Grade Gliomas
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-18
Primary completion date: 2021-08-20
Completion date: 2021-08-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03656627: Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
Official title: Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
Sponsor: Alliance Foundation Trials, LLC. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: low accrual
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-27
Primary completion date: 2021-03-18
Completion date: 2021-03-18
Plan to share individual participant data: NO
Clinical trial NCT03332836: Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus
Official title: A Phase 1, Multiple Ascending Dose, Glucose Clamp Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM12460A Compared to Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Sponsor: Hanmi Pharmaceutical Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sopnsor decision
Enrollment: 21.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-10-25
Primary completion date: 2019-01-30
Completion date: 2020-09-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05604742: Belimumab for Treatment of cGVHD Following Allo-HCT
Official title: Belimumab for Treatment of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation
Sponsor: Nanfang Hospital, Southern Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No patients eligible for inclusion
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-01
Primary completion date: 2024-12-30
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT03464019: Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
Official title: Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies
Acronym: NODE-301
Sponsor: Milestone Pharmaceuticals Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The closure of the event-driven study was terminated due to the total sample size was reached.
Enrollment: 1097.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-06-18
Primary completion date: 2023-01-20
Completion date: 2023-01-20
Baseline population: Data presented for the overall safety population including participants that received at least one dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT02793765: Docetaxel Followed by Provenge in Metastatic Prostate Cancer
Official title: Docetaxel Followed by Provenge in Castration-Resistant Prostate Cancer
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Dendreon was sold and new company decided not to fund study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-31
Primary completion date: 2018-07-31
Completion date: 2021-07-31
Plan to share individual participant data: NO
Clinical trial NCT03225287: Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study
Official title: A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: After careful consideration, UCB has decided to no longer pursue PNH as a potential indication for zilucoplan.
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-17
Primary completion date: 2021-09-07
Completion date: 2021-10-26
Baseline population: Baseline Characteristics refer to the Safety Population which consisted of all participants who received at least 1 injection of zilucoplan on or after Day 1 of the extension study.
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 NCT05700734: MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
Official title: A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business Reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-04-17
Primary completion date: 2024-02-14
Completion date: 2024-02-14
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03791918: Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria
Official title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody Versus Transarterial Chemoembolization for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-01
Primary completion date: 2022-01-01
Completion date: 2022-01-01
Clinical trial NCT01868880: Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing
Official title: Effect of Heart Rate Control Using Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Ventricular Pacing in Heart Failure Patients With an Implanted Cardioverter Defibrillator.
Sponsor: Policlinico Casilino ASL RMB (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: difficulties in recruiting patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Clinical trial NCT04990440: A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Official title: A Phase 2a, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Interventional Study to Assess the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Multiple IV Doses of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Premature study termination (efficacy)
Enrollment: 6.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-02
Primary completion date: 2022-03-09
Completion date: 2022-03-09
Limitations and caveats: The study 77474462ADM2001 (NCT04791319) was terminated due to futility analysis and no dose-response was observed. Based on study 77474462ADM2001 result, the current study (77474462ADM2003) was terminated early and thereby the planned Part C was not performed. Due to premature study termination, data collected up to Week 6 were analyzed and reported.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& 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 NCT03608020: A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy
Official title: A Safety Lead-In/Randomized Phase 2 Study of BMX-001 as a Therapeutic Agent for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy
Sponsor: BioMimetix JV, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Cessation of grant funding
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-04
Primary completion date: 2023-12-31
Completion date: 2024-04-15
Plan to share individual participant data: NO
Clinical trial NCT03688074: Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
Official title: A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)
Acronym: CASCADE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-02
Primary completion date: 2020-11-16
Completion date: 2020-11-16
Baseline population: Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
Clinical trial NCT03699124: Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial
Official title: A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN® Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Sponsor: Bavarian Nordic (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1129.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-19
Primary completion date: 2020-01-06
Completion date: 2020-06-22
Baseline population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
Limitations and caveats: There were no limitations on the trial.
Plan to share individual participant data: NO
Clinical trial NCT04990466: Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.
Official title: A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to an Approved COVID-19 Vaccine
Acronym: BRILIFE002
Sponsor: NeuroRx, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Production of the BriLife vaccine was halted by government sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2021-12-31
Completion date: 2022-02-28
Plan to share individual participant data: YES
IPD sharing description: Vaccination dates, baseline serology, and post-vaccination serology/cellular immunity/infection rates will be shared
IPD time frame: Protocol, SAP, and ICF will be shared prior to first patient visit. CSR will be shared following regulatory determination
IPD access criteria: all qualified researchers