chufangao/CTO huggingface dataset:
Clinical trial NCT04124510: Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy
Official title: An 12-week, Prospective, Interventional, Single-arm, Multi-centre, Phase III Study to Examine the Efficacy and Safety of Flutiform K-haler in Asthma Patients Who Are Not Adequately Controlled by Mid-doseICS/LABA DPI Treatment
Acronym: SWIFT
Sponsor: Mundipharma Korea Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-26
Primary completion date: 2020-09-14
Completion date: 2020-09-14
Clinical trial NCT04102111: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease
Acronym: PRISM
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: IAC completed review of futility analysis data \& determined that futility criteria were met. As a result, Janssen made decision to stop trial immediately.
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-23
Primary completion date: 2021-11-17
Completion date: 2021-12-22
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 NCT04432298: Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Official title: Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease
Sponsor: FibroGen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated by Sponsor due to low enrollment.
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-20
Primary completion date: 2021-03-22
Completion date: 2021-03-22
Baseline population: ITT population: All randomized participants.
Limitations and caveats: Due to early termination of this study, formal analyses of the primary and secondary endpoints are not presented because the study's sample size is substantially underpowered for meaningful interpretation.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03644550: Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma
Official title: Phase II Study of the Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the Food and Drug Administration's recent approval of Nivolumab plus Ipilimumab as first line treatment for Mesothelioma, the principal investigator decided to end the study early (prior to reaching enrollment goal).
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-04
Primary completion date: 2020-08-05
Completion date: 2020-11-02
Plan to share individual participant data: NO
Clinical trial NCT02125461: A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
Acronym: PACIFIC
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 713.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-05-07
Primary completion date: 2017-02-13
Completion date: 2023-08-24
Baseline population: Baseline analysis was based on the FAS consisting of all randomized patients.
Limitations and caveats: Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.
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 deidentified 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 NCT02931539: Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 352.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-22
Primary completion date: 2020-08-17
Completion date: 2020-08-17
Baseline population: The randomized set consisted of all participants who had signed an informed consent and had begun some study procedures, and randomized to the study.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT02307500: Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy
Official title: An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND
Acronym: RESOUND
Sponsor: Istituto Clinico Humanitas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 82.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-12-31
Primary completion date: 2017-12-31
Completion date: 2020-08-31
Clinical trial NCT03031730: Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma
Official title: A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Inadequate accrual rate
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-14
Primary completion date: 2024-07-24
Completion date: 2024-07-24
Clinical trial NCT04593329: Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Strategy review
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-31
Primary completion date: 2023-08-31
Completion date: 2023-12-31
Clinical trial NCT03306394: A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
Official title: An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)
Acronym: PRECONNECT
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 907.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-18
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT05417386: FOLFIRINOX + NIS793 in Pancreatic Cancer
Official title: A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: NIS793 is no longer being developed
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-09
Primary completion date: 2023-07-10
Completion date: 2023-07-10
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. 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: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT03318159: Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients
Official title: Open Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin Treatment
Sponsor: Seoul National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-20
Primary completion date: 2023-07-15
Completion date: 2023-07-15
Clinical trial NCT03681093: Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Assessment of the Efficacy in Reduction of Nasal Polyp Size in Patients With Nasal Polyposis and Concomitant Asthma.
Acronym: THUNDER
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-26
Primary completion date: 2020-05-29
Completion date: 2020-06-10
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent 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. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT03935815: Quadratus Lumborum Nerve Blocks for Myomectomies
Official title: Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Closed prior to completion secondary to surgeon leaving UCLA
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2020-06-06
Completion date: 2020-06-08
Clinical trial NCT03568071: A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability,and PK/PD of Intravenously Administered MOR106 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Acronym: IGUANA
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: MOR106 clinical development in atopic dermatitis was stopped for futility
Enrollment: 207.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-04-26
Primary completion date: 2020-03-03
Completion date: 2020-03-03
Clinical trial NCT01196390: Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
Official title: A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 203.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-02-14
Primary completion date: 2019-12-23
Completion date: 2023-08-15
Baseline population: Eligible participants
Limitations and caveats: Due to a considerable decrease in the overall rate of new disease-free survival events, the NRG Data Monitoring Committee (DMC) determined that the study would not reach the required 162 events in a reasonable amount of time. With power from the observed number of events calculated to be greater than 80%, the DMC recommended releasing the results for reporting.
Clinical trial NCT03721107: A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome
Official title: A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of Blautix in Adult Subjects With Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D
Sponsor: 4D pharma plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 366.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-11
Primary completion date: 2020-05-13
Completion date: 2020-05-13
Baseline population: Safety Analysis Set (SAF) included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Plan to share individual participant data: NO
Clinical trial NCT05479058: A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Official title: A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission
Acronym: CAPYBARA
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-26
Primary completion date: 2023-10-09
Completion date: 2023-10-09
Baseline population: Safety Analysis Set included all randomized participants who were administered study drug at least once.
Limitations and caveats: This study was terminated as the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation.
Plan to share individual participant data: NO
Clinical trial NCT02766478: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Official title: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Acronym: GeniPro
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment and study activities were suspended due to COVID-19.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-16
Primary completion date: 2021-07-23
Completion date: 2021-07-23
Plan to share individual participant data: NO
Clinical trial NCT03031821: Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome
Official title: A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study
Acronym: PRIME
Sponsor: Canadian Urologic Oncology Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Manufacturer discontinued the production of study drugs.
Enrollment: 168.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-12
Primary completion date: 2023-11-24
Completion date: 2023-11-24
Clinical trial NCT04020718: Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Official title: Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-31
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT04456153: Atovaquone for Treatment of COVID-19
Official title: Atovaquone for Treatment of COVID-19
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-22
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Limitations and caveats: This study was not powered for clinical endpoints.
Plan to share individual participant data: NO
IPD sharing description: There is no specified plan made.
Clinical trial NCT04401527: Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite
Official title: Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study
Sponsor: Hope Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-22
Primary completion date: 2020-08-15
Completion date: 2020-08-15
Clinical trial NCT03646188: Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
Official title: An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays Containing Doxorubicin (D-MNA) in Participants With Basal Cell Carcinoma (BCC)
Sponsor: SkinJect, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Application of arrays was inconsistent.
Enrollment: 13.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-06-10
Primary completion date: 2021-03-01
Completion date: 2021-05-04
Plan to share individual participant data: NO
Clinical trial NCT05447663: A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
Official title: A Phase Ib/II, Open Label Study of Siremadlin Monotherapy and in Combination With Donor Lymphocyte Infusion as a Treatment for Patients With Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplantation Who Are in Complete Remission But at High Risk for Relapse.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study has been stopped following to strategic decision from the Sponsor. Not based on any safety findings or safety concerns with siremadlin.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-02-23
Primary completion date: 2023-10-26
Completion date: 2023-10-26
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent 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. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com