<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04401020</url>
  </required_header>
  <id_info>
    <org_study_id>TED16364</org_study_id>
    <secondary_id>2019-003390-26</secondary_id>
    <secondary_id>U1111-1244-2511</secondary_id>
    <nct_id>NCT04401020</nct_id>
  </id_info>
  <brief_title>First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL</brief_title>
  <official_title>An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in&#xD;
      patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory&#xD;
      non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To characterize the safety profile of SAR442257&#xD;
&#xD;
        -  To characterize the pharmacokinetics (PK) profile of SAR442257&#xD;
&#xD;
        -  To evaluate the potential immunogenicity of SAR442257&#xD;
&#xD;
        -  To assess preliminary evidence of antitumor activity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this&#xD;
      study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of&#xD;
      data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Anticipated">April 15, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine maximum tolerated dose (MTD)</measure>
    <time_frame>Baseline to estimated 4 weeks</time_frame>
    <description>MTD: defined as the highest dose level (DL) with highest probability of Investigational Medicinal Product (IMP)-related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (&gt;33%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine recommended Phase 2 dose (RP2D)</measure>
    <time_frame>Baseline to estimated 4 months</time_frame>
    <description>RP2D: defined as the dose selected for the further single agent testing in the future study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with AEs/SAEs/AESI</measure>
    <time_frame>Baseline to 30 days after end of treatment</time_frame>
    <description>Incidence of treatment-emergent adverse events (AEs)/serious adverse events (SAEs)/ adverse events of special interest (AESIs) and laboratory abnormalities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of pharmacokinetic (PK) parameter: Cmax</measure>
    <time_frame>through study completion (estimated 16 months)</time_frame>
    <description>Maximum concentration observed (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: Ctrough</measure>
    <time_frame>through study completion (estimated 16 months)</time_frame>
    <description>Concentration observed just before treatment administration during repeated dosing (Ctrough)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: AUC0-τ</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Area under the concentration versus time curve during a dosing interval (T) (AUC0-τ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of anti-drug antibody (ADA)</measure>
    <time_frame>Baseline to 60 days after end of treatment</time_frame>
    <description>Incidence of (ADA) against SAR442257</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate for RRMM</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Overall response rate will be assessed using the International Myeloma Working Group (IMWG) 2016 criteria for patients with RRMM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate for RR-NHL</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Overall response rate will be assessed using the Response evaluation criteria in lymphoma (RECIL) 2017 criteria for patients with RR-NHL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">57</enrollment>
  <condition>Neoplasm Malignant</condition>
  <arm_group>
    <arm_group_label>Dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAR442257</intervention_name>
    <description>Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion</description>
    <arm_group_label>Dose escalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
        Participant must be at least 18 years of age or of the country's legal age of majority if&#xD;
        the legal age is &gt;18 years old, at the time of signing the informed consent.&#xD;
&#xD;
        Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance&#xD;
        status ≤2.&#xD;
&#xD;
        RRMM patients:&#xD;
&#xD;
        must have received at least 3 prior lines of therapy including proteasome inhibitor (PI),&#xD;
        immunomodulatory agent (IMiD), and anti-CD38 mAb;&#xD;
&#xD;
        and must be refractory to anti-CD38 antibody (eg, daratumumab or isatuximab), characterized&#xD;
        by progression within 60 days of the last dose of anti-CD38, regardless of which line it&#xD;
        was given; and must be either relapsed or refractory to all established therapies with&#xD;
        known clinical benefit in RRMM where approved and available, or are intolerant to those&#xD;
        established therapies; based upon investigator's clinical judgement.&#xD;
&#xD;
        and must not be candidates for regimens known to provide clinical benefit based upon&#xD;
        investigator's clinical judgement.&#xD;
&#xD;
        Patients with RRMM must have measurable disease as per the following:&#xD;
&#xD;
          -  Serum M protein ≥0.5 g/dL (≥5 g/L), or&#xD;
&#xD;
          -  Urine M protein ≥200 mg/24 hours, or&#xD;
&#xD;
          -  Serum free light chain (FLC) assay: involved FLC assay ≥10 mg/dL and an abnormal serum&#xD;
             FLC ratio (&lt;0.26 or &gt;1.65).&#xD;
&#xD;
        Patients with RR-NHL must be relapsed or refractory to all established therapies with known&#xD;
        clinical benefit where approved and available, or are intolerant to those established&#xD;
        therapies; based upon investigator's clinical judgement.&#xD;
&#xD;
        Patients with RR-NHL must have measurable disease of at least one lesion ≥1.5 cm as&#xD;
        documented by computed tomography (CT) scan, including the following subtype of disease:&#xD;
&#xD;
          -  Diffuse large B-cell lymphoma (DLBCL).&#xD;
&#xD;
          -  HGBCL with MYC and/or BCL2 and/or BCL6 rearrangement or HGBCL NOS,&#xD;
&#xD;
          -  transformed follicular lymphoma (tFL),&#xD;
&#xD;
          -  follicular lymphoma (FL),&#xD;
&#xD;
          -  mantle cell lymphoma (MCL),&#xD;
&#xD;
          -  marginal zone lymphoma (MZL),&#xD;
&#xD;
          -  lymphoplasmacytic lymphoma,&#xD;
&#xD;
          -  small lymphocytic lymphoma (SLL). Patients with RR-NHL subtype T cell lymphoma (TCL)&#xD;
             including the following subtype of disease: Nodal peripheral TCL including&#xD;
             angio-immunoblastic TCL (AITL), anaplastic large cell lymphoma (ALCL), adult T cell&#xD;
             leukemia-lymphoma, and peripheral TCL NOS (not otherwise specified). Peripheral TCL of&#xD;
             the innate immune system: breast implant ALCL, extranodal NK/TCL, enteropathy&#xD;
             associated TCL, monomorphic epitheliotropic intestinal TCL, and hepatosplenic TCL.&#xD;
             histopathologically confirmed mycosis fungoides or Sézary syndrome (cutaneous T cell&#xD;
             lymphoma [CTCL] stage IIB or greater according to the European Organization for&#xD;
             Research and Treatment of Cancer/International Society for Cutaneous Lymphomas&#xD;
             [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or&#xD;
             recurrent disease who have no available remaining standard therapeutic options (ie,&#xD;
             refractory) as determined by the Investigator.&#xD;
&#xD;
        Patients with lymphoma must have availability of lymphoma tissue for biomarker testing:&#xD;
        either archived tissue or a fresh biopsy as a part of screening. On-treatment biopsy (Cycle&#xD;
        2 or beyond) is also expected if disease location is in a superficial lymph node. For&#xD;
        post-CAR-T patients a fresh LN biopsy is expected if in a superficial node. For these&#xD;
        patients tissue materials should be made available for analysis during the study.&#xD;
        Excisional biopsy or resected tissue is required if clinically feasible; otherwise, core&#xD;
        needle biopsy is acceptable. Fine needle aspirates are not acceptable.&#xD;
&#xD;
        Patients with lymphoma must have a ≥50% left ventricular ejection fraction (LVEF) and no&#xD;
        pericardial effusion, as measured by echocardiogram (ECHO).&#xD;
&#xD;
        Contraceptive use by men or women should be consistent with local regulations regarding the&#xD;
        methods of contraception for those participating in clinical studies.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Diagnosed or treated for another malignancy within 3 years prior to enrollment, except for&#xD;
        basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy,&#xD;
        superficial bladder carcinoma or low risk prostate cancer.&#xD;
&#xD;
        Amyloidosis, chronic lymphocytic leukemia and prolymphocytic leukemia. Known central&#xD;
        nervous system (CNS) involvement by myeloma, lymphoma or other CNS disease such as&#xD;
        neurodegenerative condition or CNS movement disorder.&#xD;
&#xD;
        Has congestive heart failure (New York Heart Association) Grade ≥II; cardiomyopathy, active&#xD;
        ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically&#xD;
        significant arrhythmia requiring therapy including anticoagulants, or clinically&#xD;
        significant uncontrolled hypertension, QT interval corrected by the Fridericia method &gt;480&#xD;
        msec (Grade ≥2). Acute myocardial infarction within 6 months before start of study&#xD;
        treatment.&#xD;
&#xD;
        Has active autoimmune disease including autoimmune hemolytic anemia, idiopathic&#xD;
        thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition&#xD;
        requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.&#xD;
&#xD;
        Clinically-not controlled chronic or ongoing infectious disease requiring treatment at the&#xD;
        time of first dose or within the 14 days before first dose.&#xD;
&#xD;
        Active hepatitis A, B, and C as defined below: active hepatitis A (defined as positive&#xD;
        IgM), active hepatitis B (defined as either positive hepatitis B surface antigen or&#xD;
        positive hepatitis B viral DNA test above the lower limit of detection of the assay, and&#xD;
        hepatitis B core antibodies), or C infection (defined as a known positive hepatitis C&#xD;
        antibody result and known quantitative hepatitis C [HCV] ribonucleic acid [RNA] results&#xD;
        greater than the lower limits of detection of the assay).&#xD;
&#xD;
        Known positivity for Human Immunodeficiency Virus (HIV). Unresolved toxicities from prior&#xD;
        anticancer therapy, defined as not having resolved to Common Terminology Criteria for&#xD;
        Adverse Events (CTCAE) version 5.0 Grade 1 or to levels dictated in the eligibility&#xD;
        criteria with the exception of Grade 1 peripheral neuropathy, alopecia or toxicities from&#xD;
        prior anticancer therapy that are considered irreversible (defined as having been present&#xD;
        and stable for &gt;4 weeks) which may be allowed if they are not otherwise described in the&#xD;
        exclusion criteria.&#xD;
&#xD;
        Participant not suitable for participation, whatever the reason, as judged by the&#xD;
        Investigator, including medical or clinical conditions, or participants potentially at risk&#xD;
        of noncompliance to study procedures.&#xD;
&#xD;
        Sensitivity to any of the study interventions, or components thereof, or drug or other&#xD;
        allergy that, in the opinion of the Investigator, contraindicates participation in the&#xD;
        study.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Trial Transparency email recommended (Toll free number for US &amp; Canada)</last_name>
    <phone>800-633-1610</phone>
    <phone_ext>option 6</phone_ext>
    <email>Contact-US@sanofi.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope-Site Number:8400001</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Miami - Sylvester Comprehensive Cancer Center-Site Number:8400005</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic of Rochester-Site Number:8400003</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100001</name>
      <address>
        <city>Seoul</city>
        <state>Seoul-teukbyeolsi</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100002</name>
      <address>
        <city>Seoul</city>
        <state>Seoul-teukbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5780001</name>
      <address>
        <city>Oslo</city>
        <zip>0440</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5780101</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240003</name>
      <address>
        <city>Badalona</city>
        <state>Catalunya [Cataluña]</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240006</name>
      <address>
        <city>Madrid</city>
        <state>Madrid, Comunidad De</state>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240001</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240004</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czechia</country>
  </removed_countries>
  <verification_date>July 12, 2023</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04401020
org study id: TED16364
secondary id: 2019-003390-26
secondary id: U1111-1244-2511
nct id: NCT04401020
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Primary Objective:

      To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in
      patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory
      non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)

      Secondary Objectives:

        -  To characterize the safety profile of SAR442257

        -  To characterize the pharmacokinetics (PK) profile of SAR442257

        -  To evaluate the potential immunogenicity of SAR442257

        -  To assess preliminary evidence of antitumor activity
Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this
      study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of
      data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine maximum tolerated dose (MTD)
time frame: Baseline to estimated 4 weeks
description: MTD: defined as the highest dose level (DL) with highest probability of Investigational Medicinal Product (IMP)-related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (>33%)
measure: Determine recommended Phase 2 dose (RP2D)
time frame: Baseline to estimated 4 months
description: RP2D: defined as the dose selected for the further single agent testing in the future study
measure: Number of participants with AEs/SAEs/AESI
time frame: Baseline to 30 days after end of treatment
description: Incidence of treatment-emergent adverse events (AEs)/serious adverse events (SAEs)/ adverse events of special interest (AESIs) and laboratory abnormalities
measure: Assessment of pharmacokinetic (PK) parameter: Cmax
time frame: through study completion (estimated 16 months)
description: Maximum concentration observed (Cmax)
measure: Assessment of PK parameter: Ctrough
time frame: through study completion (estimated 16 months)
description: Concentration observed just before treatment administration during repeated dosing (Ctrough)
measure: Assessment of PK parameter: AUC0-τ
time frame: up to 4 weeks
description: Area under the concentration versus time curve during a dosing interval (T) (AUC0-τ)
measure: Incidence of anti-drug antibody (ADA)
time frame: Baseline to 60 days after end of treatment
description: Incidence of (ADA) against SAR442257
measure: Overall response rate for RRMM
time frame: Baseline to 6 months
description: Overall response rate will be assessed using the International Myeloma Working Group (IMWG) 2016 criteria for patients with RRMM
measure: Overall response rate for RR-NHL
time frame: Baseline to 6 months
description: Overall response rate will be assessed using the Response evaluation criteria in lymphoma (RECIL) 2017 criteria for patients with RR-NHL
arm group label: Dose escalation
arm group type: Experimental
description: SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s).
intervention type: Drug
intervention name: SAR442257
description: Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion
arm group label: Dose escalation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
last name: Trial Transparency email recommended (Toll free number for US & Canada)
phone: 800-633-1610
phone ext: option 6
email: Contact-US@sanofi.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Korea, Republic of
country: Norway
country: Spain
country: United States
country: Czechia
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Yes
ipd 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