chufangao/CTO huggingface dataset:
Clinical trial NCT03920254: TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Official title: A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)
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: 46.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-23
Primary completion date: 2021-10-27
Completion date: 2021-10-27
Baseline population: The Baseline Analysis Population includes all participants from the Safety Analysis Set. The Safety Analysis Set includes all participants who received at least one dose of study drug.
Limitations and caveats: Study 0164 was terminated early because Study 0157 was terminated early and participation in Study 0164 was predicated on participation in Study 0157.
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 NCT04056299: Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Official title: Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Sponsor: Aimmune Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was prematurely terminated by the Sponsor based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-20
Primary completion date: 2020-12-16
Completion date: 2020-12-28
Plan to share individual participant data: NO
Clinical trial NCT03040726: Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Official title: Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-03
Primary completion date: 2022-02-14
Completion date: 2022-02-14
Baseline population: We have 2 arms in this study (intervention group and Placebo group) during randomization. These 2 arms included all participants who entered in Placebo run out phase. Baseline characteristics thus have 2 arms/groups.
Clinical trial NCT04031066: Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis
Acronym: SHAMAN
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Big delay on study activation (approval procedures by IRBs, hospitals contract negotiation) and on enrolment deadline due to CoViD-19; Placebo stock expires November 2021 and new batch not be available for at least one year
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-11
Primary completion date: 2021-10-27
Completion date: 2021-12-29
Plan to share individual participant data: NO
Clinical trial NCT04531865: Randomized Trial Evaluating Mycophenolate Mofetil in Children With Nephrotic Syndrome After Rituximab Treatment
Official title: Efficacy and Safety of Mycophenolate Mofetil as Maintenance Therapy After Rituximab Treatment in Childhood-onset, Frequently-relapsing or Steroid-dependent Nephrotic Syndrome: a Multicenter Double-blind, Randomized, Placebo-controlled Trial
Sponsor: Children's Hospital of Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2022-09-01
Completion date: 2022-10-01
Clinical trial NCT03080935: Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
Official title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Amgen business decision to close study early
Enrollment: 1600.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-13
Primary completion date: 2022-03-04
Completion date: 2022-03-04
Baseline population: The Overall Number of Baseline Participants is made up of all of the participants that received study drug.
Limitations and caveats: This study was terminated to coincide with the completion of study 20130295 (NCT02867813). The study was not terminated due to any safety findings.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT04607200: AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma
Official title: A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination With AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma
Sponsor: Agenus Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Strategic business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-28
Primary completion date: 2021-09-13
Completion date: 2021-09-13
Clinical trial NCT01803438: Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
Official title: Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.
Sponsor: Medtronic Cardiac Rhythm and Heart Failure (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 220.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-30
Primary completion date: 2019-10-16
Completion date: 2020-01-20
Clinical trial NCT02389959: Intranasal Bevacizumab for HHT-Related Epistaxis
Official title: Intranasal Bevacizumab for HHT-Related Epistaxis
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-08-04
Primary completion date: 2020-01-23
Completion date: 2020-01-23
Baseline population: 1 participant did not complete the baseline questionnaires.
Clinical trial NCT04327388: Sarilumab COVID-19
Official title: An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 420.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-03-28
Primary completion date: 2020-07-31
Completion date: 2020-09-02
Baseline population: Analysis was performed on randomized population.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT03513952: Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma
Official title: A Randomized Phase II Study of Atezolizumab (MPDL3280A) Plus Recombinant Human IL7 (CYT107) in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-05
Primary completion date: 2023-09-30
Completion date: 2024-04-01
Clinical trial NCT05033132: A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer
Official title: An Open-label, Multicenter Phase II Study Evaluating Balstilimab Alone or Balstilimab in Combination With Zalifrelimab in Patients With Advanced Cervical Cancer
Sponsor: Agenus Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was never initiated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-01
Primary completion date: 2024-12-30
Completion date: 2024-12-30
Clinical trial NCT02774317: Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months
Official title: A Pilot Study to Compare the Use of Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The clinical team couldn't recruit patients who met the criteria for enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-31
Primary completion date: 2020-06-30
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT05703555: INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Official title: INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Acronym: INTRUSION
Sponsor: Erasmus Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to the decision to discontinue the global clinical development program of tusamitamab ravtansine
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-02-16
Primary completion date: 2024-02-16
Completion date: 2024-02-16
Plan to share individual participant data: YES
IPD sharing description: By means of a publication in a peer-reviewed international journal
IPD time frame: Within 12 months of last visit of last patient
Clinical trial NCT03229499: Pulmonary Hypertension and Anastrozole Trial
Official title: Pulmonary Hypertension and Anastrozole Trial (PHANTOM)
Acronym: PHANTOM
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-07
Primary completion date: 2022-07-22
Completion date: 2022-07-22
Clinical trial NCT03735290: A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer
Official title: A Randomized, Open-label, Multi-center, Phase 1b/2 Trial Evaluating the Safety and Efficacy of Intratumorally-administered Ilixadencel in Combination With Checkpoint Inhibitor (CPI) in Advanced Cancer Subjects Who Are Candidates for CPI Therapy
Acronym: ILIAD
Sponsor: Mendus (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Decision made not to move to Phase 2
Enrollment: 21.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-01-14
Primary completion date: 2021-12-03
Completion date: 2021-12-03
Plan to share individual participant data: NO
Clinical trial NCT01066234: Adjuvant CCRT vs CT in Minimal N2 NSCLC
Official title: A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer
Sponsor: Samsung Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-23
Primary completion date: 2021-01-18
Completion date: 2021-01-18
Clinical trial NCT02659943: T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
Official title: T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-01-21
Primary completion date: 2018-06-12
Completion date: 2022-12-31
Baseline population: Baseline data was collected and reported here for the participants enrolled but not treated.
Plan to share individual participant data: NO
Clinical trial NCT00774345: A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 317.0 (ACTUAL)
Number of arms: 2.0
Start date: 2009-01-27
Primary completion date: 2020-10-27
Completion date: 2020-10-27
Clinical trial NCT05387642: A Clinical Trial of PRAX-114 in Participants With Essential Tremor
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of PRAX-114 in the Treatment of Adults With Essential Tremor
Sponsor: Praxis Precision Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor no longer pursuing indication.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-05
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Clinical trial NCT01981551: Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis
Official title: Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-10-31
Primary completion date: 2018-12-30
Completion date: 2023-12-01
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
IPD time frame: Clinical data available during the study and indefinitely.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Clinical trial NCT04510428: OSIG-eye Drops Treatment for Dry Eye Disease
Official title: A Phase II Randomized Placebo-Controlled, Double Blind, Single-Center, Tolerability and Efficacy Clinical Trial of Ocular Surface Immunoglobulin (OSIG) Eye Drops In Patients With Dry Eye Disease
Sponsor: University of Illinois at Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study not initiated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-05-15
Primary completion date: 2023-11-30
Completion date: 2024-01-20
Plan to share individual participant data: NO
Clinical trial NCT04996030: A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia
Official title: An Open-label Phase 1 Study to Evaluate Pharmacokinetics, Safety, and Tolerability of SY-2101 in Adult Patients With Acute Promyelocytic Leukemia
Sponsor: Syros Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Prioritization
Enrollment: 16.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-09-17
Primary completion date: 2024-01-03
Completion date: 2024-04-30
Plan to share individual participant data: NO
Clinical trial NCT04809116: Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept
Official title: Open-label Pimavanserin 34mg at Bedtime for 6 Weeks for Insomnia in Veterans With Post-traumatic Stress Disorder: Proof of Concept Study
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Received alternative sources of funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-15
Primary completion date: 2023-12-15
Completion date: 2023-12-15
Plan to share individual participant data: NO
Clinical trial NCT03529773: A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY ADULTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1235.0 (ACTUAL)
Number of arms: 20.0
Start date: 2018-04-18
Primary completion date: 2019-11-20
Completion date: 2020-12-28
Baseline population: Safety analysis set included all participants in the sentinel and expanded cohorts who received at least 1 dose of the investigational products.
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.
IPD time frame: Starting 24 months after study completion.
Clinical trial NCT03742596: Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal Cancer Patients
Official title: Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy on the Immune System Among Colorectal Cancer Patients
Sponsor: King Hussein Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: This study was closed without recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-07
Primary completion date: 2022-09-30
Completion date: 2022-12-30
Plan to share individual participant data: NO
IPD sharing description: The center (KHCC) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
Clinical trial NCT04360759: Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19
Official title: Multi-centre Randomised Controlled Trial of Chloroquine/Hydroxychloroquine Versus Standard of Care for Treatment of Mild Covid-19 in HIV-positive Outpatients in South Africa
Acronym: CQOTE
Sponsor: University of Cape Town (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Equipoise for hydroxychloquine was lost
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-01
Primary completion date: 2021-05-30
Completion date: 2021-06-30
Plan to share individual participant data: YES
IPD sharing description: Data collected from this study may be made available to other international researchers and institutions who are working to control this Public Health Emergency, but in a fully anonymized way. No personal identifiers will be available anywhere in the data. Dates will either not be included or will be shifted by a random interval so as to not make it possible to trace any identity.
IPD time frame: Recruitment period is planned for a maximum of 12 months, rate dependent on patient numbers. Additional sites will be opened after initial approvals.
Clinical trial NCT03217838: Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
Official title: A Phase I/II, Open-Label, Multicentre 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia Patients Not Eligible for Intensive Induction Therapy.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: strategic decision
Enrollment: 50.0 (ACTUAL)
Number of arms: 13.0
Start date: 2017-07-31
Primary completion date: 2021-03-25
Completion date: 2021-03-25
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.
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.