chufangao/CTO huggingface dataset:
Clinical trial NCT02877134: Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease
Acronym: TRIDENT
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 388.0 (ACTUAL)
Number of arms: 7.0
Start date: 2016-08-25
Primary completion date: 2020-12-10
Completion date: 2022-01-24
Clinical trial NCT04484428: A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
Official title: A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
Sponsor: Kowa Research Institute, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Internal business decision
Enrollment: 126.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-15
Primary completion date: 2021-03-19
Completion date: 2021-03-19
Clinical trial NCT02978222: Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer
Official title: A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy
Sponsor: Marker Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Futility analysis did not support continuation of the trial
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-20
Primary completion date: 2020-01-15
Completion date: 2020-01-15
Limitations and caveats: The trial was stopped due futility. Therefore, results are not for the complete study as designed.
Plan to share individual participant data: NO
Clinical trial NCT04535362: Nicotine's Potential Abuse With Menthol
Official title: Impact of Menthol on the Abuse Potential of Nicotine
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-28
Primary completion date: 2023-06-29
Completion date: 2023-06-29
Baseline population: Participants randomized to one of two crossover arms.
Clinical trial NCT04467853: A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors
Official title: A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C18S, an CAR-T Cell Therapy Targeting Claudin18.2 in Patients With Advanced Solid Tumors
Sponsor: Shanghai East Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Both the sponsors and collaborator are considering terminating the study
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-21
Primary completion date: 2023-07-17
Completion date: 2023-07-17
Plan to share individual participant data: NO
Clinical trial NCT03638011: A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine
Official title: A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel)
Sponsor: Maimonides Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Standard of Care changed due to COVID-19 and thus had to stop the study.
Enrollment: 71.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-25
Primary completion date: 2020-03-31
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT02906332: Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM)
Official title: A Phase II Trial of the Anti -PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) + Lenalidomide + Dexamethasone as Post Autologous Transplant Consolidation in Patients With High-risk Multiple Myeloma
Sponsor: Hackensack Meridian Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: FDA Hold Due to Updated Risks
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-12
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Plan to share individual participant data: NO
Clinical trial NCT01727401: Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia
Official title: Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
Acronym: FAITH
Sponsor: G. d'Annunzio University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow recruitment rate
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-11-30
Primary completion date: 2021-07-31
Completion date: 2021-07-31
Clinical trial NCT03758443: Efficacy & Safety of TD-1473 in Ulcerative Colitis
Official title: A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis
Acronym: RHEA
Sponsor: Theravance Biopharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.
Enrollment: 239.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-11
Primary completion date: 2021-10-20
Completion date: 2021-10-20
Baseline population: The Intent-to-treat population included all randomized participants.
Limitations and caveats: The study was terminated early due to a company decision based on interim analysis results in TD-1473-0157. Therefore, the Phase 3 dose-confirming Induction Study was not conducted and the Maintenance Study was prematurely terminated.
Plan to share individual participant data: NO
IPD sharing description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Clinical trial NCT04978493: A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 49.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-04
Primary completion date: 2024-07-08
Completion date: 2024-08-08
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT02663908: A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Official title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)
Acronym: PRONOUNCE
Sponsor: Ferring Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recruitment rate; a lower than anticipated observed cardiovascular event rate. The Sponsor decision to stop the trial was not based on any safety concerns or any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.
Enrollment: 545.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-19
Primary completion date: 2021-03-29
Completion date: 2021-03-29
Baseline population: The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.
Limitations and caveats: The trial was terminated prematurely due to a slower than anticipated recruitment rate and a lower than anticipated observed CV event rate. Approximately 900 patients were planned to be included, however, at the time of stopping screening and recruitment 216 patients had completed the trial, 292 were ongoing, and 37 were withdrawn. The Sponsor decision to stop the trial was not based on any safety concerns, any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.
Clinical trial NCT04322708: A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
Official title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis
Acronym: KRYPTOS
Sponsor: Allakos Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 277.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-06
Primary completion date: 2021-06-04
Completion date: 2022-01-18
Baseline population: Modified Intention-to-treat
Plan to share individual participant data: NO
Clinical trial NCT02282358: Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Official title: An Open-Label Phase II Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of accrual
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-10-31
Primary completion date: 2023-05-26
Completion date: 2023-05-26
Clinical trial NCT05318443: A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer
Official title: A Randomized, Double-blind, Parallel-controlled Study Comparing the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (SIBP04) and Bevacizumab Injection (Avastin) in Combination With Paclitaxel and Carboplatin Respectively in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.
Sponsor: Shanghai Institute Of Biological Products (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 512.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2022-12-26
Completion date: 2023-01-12
Plan to share individual participant data: NO
Clinical trial NCT04035109: Anakinra as a Rescue Treatment for Allergic Inflammation
Official title: Anakinra as a Rescue Treatment for Nasal Allergen Challenge-induced Airway Inflammation
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Study stopped due to COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-16
Primary completion date: 2022-10-31
Completion date: 2023-10-31
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD time frame: 9 to 36 months following publication
IPD access criteria: Approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execution of a data use/sharing agreement with UNC.
Clinical trial NCT02957019: A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official title: A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Sponsor: Philogen S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Slow progression due to difficulties in finding eligible patients. Competitive clinical trials with innovative agents and new approved products leaddefinitive stop.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-07-31
Primary completion date: 2023-09-30
Completion date: 2023-09-29
Clinical trial NCT03308786: HIV Reservoir Reduction With Interleukin-2
Official title: HIV Reservoir Reduction With Interleukin-2
Acronym: IL2
Sponsor: Case Western Reserve University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: There were 3 instances of adverse events which were discussed with external safety monitoring committee and it was recommended that the study be terminated.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-01
Primary completion date: 2020-08-20
Completion date: 2020-08-20
Limitations and caveats: On the basis of recommendation of the SMC, the study was terminated. Because of this, the primary objective could not be achieved and most of the secondary objectives could not be achieved.
Plan to share individual participant data: NO
Clinical trial NCT05934942: A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
Official title: An Open-label, Fixed-sequence Cross-over, Two-period, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of a Combination of Ethinylestradiol and Drospirenone in Healthy Female Subjects
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-09-08
Primary completion date: 2024-02-08
Completion date: 2024-02-08
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).~For more details refer to:~https://www.mystudywindow.com/msw/datatransparency
Clinical trial NCT02656914: Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
Official title: Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2020-06-30
Completion date: 2020-09-30
Clinical trial NCT03830281: A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Acronym: PRONTO-Pump-2
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 471.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-14
Primary completion date: 2020-01-06
Completion date: 2020-01-06
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04195906: Phase 3 Study of SNF472 for Calciphylaxis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis
Acronym: Calciphyx
Sponsor: Sanifit Therapeutics S. A. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 71.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-12
Primary completion date: 2022-10-24
Completion date: 2022-10-24
Baseline population: Modified Intent-to-treat Population (mITT): The modified mITT population was defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation.~The mITT population was the primary analysis population for efficacy endpoints.
Plan to share individual participant data: NO
Clinical trial NCT04267822: Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV
Official title: Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of RV521 in the Treatment of Adult Subjects Who Have Undergone Hematopoietic Cell Transplantation (HCT) With a Documented Upper Respiratory Tract Infection (URTI) With Respiratory Syncytial Virus (RSV)
Acronym: REVIRAL2
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-15
Primary completion date: 2023-06-30
Completion date: 2023-07-31
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 NCT04345107: Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus
Official title: A Phase Ib Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SY-009 After Multiple Ascending Doses in Patients With Type 2 Diabetes Mellitus
Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-05-01
Primary completion date: 2021-04-29
Completion date: 2021-09-21
Clinical trial NCT00660673: Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Official title: Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 262.0 (ACTUAL)
Number of arms: 1.0
Start date: 2009-11-13
Primary completion date: 2021-11-30
Completion date: 2021-11-30
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT03235986: A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
Official title: A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Change in the benefit-risk balance
Enrollment: 166.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-28
Primary completion date: 2020-05-05
Completion date: 2020-05-05
Plan to share individual participant data: NO