xml: <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/NCT06034509</url>
    </required_header>
    <id_info>
      <org_study_id>WRNMMC-2022-0409</org_study_id>
      <secondary_id>W81XWH-22-2</secondary_id>
      <nct_id>NCT06034509</nct_id>
    </id_info>
    <brief_title>Cognitive and Vascular Functioning Following TBI</brief_title>
    <official_title>Cognitive and Vascular Functioning Following TBI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Walter Reed National Military Medical Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Walter Reed National Military Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This observational study will examine the association of chronic traumatic cerebrovascular&#xD;
        injury and cardiovascular risk factors with TBI-related cognitive impairment and vascular&#xD;
        dementia. Cerebrovascular, inflammatory, and neurodegenerative blood biomarkers as well as&#xD;
        clinical and neuroimaging data&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will enroll 300 Service Members (SMs) and Veterans who participated in the&#xD;
        National Intrepid Center of Excellence (NICoE) intensive outpatient program or Defense and&#xD;
        Veterans Brain Injury Center/Traumatic Brain Injury Center of Excellence (DVBIC/TBICoE)&#xD;
        15-Year TBI Natural History of TBI Study (NatHx) at least three years prior to the present&#xD;
        evaluation and provided prior blood specimens stored for analysis. Following informed&#xD;
        consent, participants will undergo semi-structured interviews assessing posttraumatic stress&#xD;
        disorder (PTSD) and updated lifetime TBI history, neurological examination,&#xD;
        neuropsychological testing, structural Magnetic Resonance Imaging (MRI) T1, T2, fluid&#xD;
        attenuated inversion recovery (FLAIR), diffuse tensor imaging (DTI), as well as novel imaging&#xD;
        techniques to assess imaging biomarkers of traumatic cerebrovascular injury (TCVI): 1)&#xD;
        functional MRI (fMRI)-Blood Oxygen Level Dependent (BOLD) with hypercapnia challenge to&#xD;
        measure cerebrovascular reactivity (CVR); and 2) Dynamic Contrast Enhanced-MRI to assess&#xD;
        blood brain barrier integrity, and an additional research blood draw [apolipoprotein E (APOE)&#xD;
        genotype; plasma biomarkers including vascular (e.g., vascular endothelial growth factor, von&#xD;
        Willebrand Factor, cholesterol, homocysteine), inflammatory (e.g., high sensitivity&#xD;
        c-reactive protein, interleukin-6 (IL-6), chitinase-3-like protein 1 (YKL-40)), and neuronal&#xD;
        degeneration (e.g., neurofilament light, phosphorylated tau, brain-derived neurotrophic&#xD;
        factor, beta amyloid proteins)]. A medical record review will be conducted specifically for&#xD;
        current and past history of cerebrovascular risk factors (e.g., hypertension, diabetes,&#xD;
        tobacco use) and psychological conditions (e.g., PTSD, depression). The project will also&#xD;
        leverage previously collected data, comparing participants' symptoms, cognitive performance,&#xD;
        imaging, and, blood biomarkers to those previously collected through the NICoE, 15-Year study&#xD;
        and/or the DOD serum repository, with data from at least two time points on all individuals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Panel of blood biomarkers</measure>
      <time_frame>3 years</time_frame>
      <description>A panel of blood biomarkers including vascular (e.g., vascular endothelial growth factor, von Willebrand Factor, cholesterol, lipoproteins, homocysteine, fibrinogen, hemoglobin A1C), inflammatory (e.g., high sensitivity c-reactive protein, Tumor Necrosis Factor-alpha, IL-6, IL-12p70, YKL-40), and neuronal degeneration (e.g., neurofilament light, Glial Fibrillary Acidic Protein, phosphorylated tau, Clusterin, brain-derived neurotrophic factor, beta amyloid proteins) will be compared between TBI groups. One-way ANOVAs will be run with TBI severity as the independent variable and each individual blood biomarker (measured in pg/mL) as the dependent variable. Spearman's rank order correlations will evaluate the relationship between blood biomarkers, number of TBIs, and TBI severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Performance- Overall Test Battery Mean</measure>
      <time_frame>3 years</time_frame>
      <description>Neurocognitive data will be corrected for age, gender, education, and race, as available. An overall test battery mean (OTBM) T-score will be calculated as the average of seven cognitive domain T-scores (attention/processing speed, working memory, executive functioning, learning/immediate memory, delayed memory, language, perceptual reasoning). Each biomarker will be correlated with the OTBM using Spearman's rank order correlations. Cognitive domain T-scores will also be evaluated to understand which are driving changes in the OTBM. All scores will be evaluated as T-scores (mean=50, SD=10, min=0, max=100), for which higher scores indicate higher cognitive performance. Multivariable logistic regression will be used to evaluate the relationship between TBI number, TBI severity, blood biomarkers and normal cognition vs. mild cognitive impairment (MCI).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in panel of blood biomarkers over time</measure>
      <time_frame>3 years</time_frame>
      <description>Linear mixed effect (LME) models will be fit to the analysis dataset which use the panel of blood biomarkers as the response variables and investigate TBI severity, number of TBI events, and time. The panel of blood biomarkers will include vascular (e.g., vascular endothelial growth factor, von Willebrand Factor, cholesterol, lipoproteins, homocysteine, fibrinogen, hemoglobin A1C), inflammatory (e.g., high sensitivity c-reactive protein, Tumor Necrosis Factor-alpha, IL-6, IL-12p70, YKL-40), and neuronal degeneration (e.g., neurofilament light, Glial Fibrillary Acidic Protein, phosphorylated tau, Clusterin, brain-derived neurotrophic factor, beta amyloid proteins) biomarkers, all measured in pg/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in overall test battery mean over time</measure>
      <time_frame>3 years</time_frame>
      <description>The investigators will fit a cross-sectional multivariable regression model to the data with the response variable being the change (Time 3 - Time 2) in the OTBM T-score (mean=50, SD=10, min=0, max=100). Individual cognitive domain composite T-scores will also be evaluated to understand the main components driving change in the OTBM.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in brain volume over time</measure>
      <time_frame>3 years</time_frame>
      <description>The investigators will fit a cross-sectional multivariable regression model to the data with the response variable being the change (Time 3 - Time 2) in total brain volume [milliliters (mL)].</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in white matter lesions over time</measure>
      <time_frame>3 years</time_frame>
      <description>The investigators will fit a cross-sectional multivariable regression model to the data with the response variable being the change (Time 3 - Time 2) in total and total number of white matter lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cerebrovascular Reactivity</measure>
      <time_frame>3 years</time_frame>
      <description>Linear regression models will be run with the difference score in each vascular blood biomarker from the initial visit to the current study visit as the independent variable and global CVR (%S/mmHG) - (assessed during the current visit only) as the dependent variable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCE-MRI</measure>
      <time_frame>3 years</time_frame>
      <description>Linear regression models will be run with the difference score in each vascular blood biomarker from the initial visit to the current study visit as the independent variable and overall blood brain barrier function (assessed during the current visit only as the percentage of brain volume with suprathreshold voxels) as the dependent variable.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Traumatic Brain Injury</condition>
    <condition>Cognitive Decline</condition>
    <condition>Vascular Dementia</condition>
    <arm_group>
      <arm_group_label>TBI Group</arm_group_label>
      <description>Participants in this group will have been identified as sustaining a traumatic brain injury (mild, moderate, severe, or penetrating).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High-blast exposed control group</arm_group_label>
      <description>Participants in this group will have no history of traumatic brain injury AND will have a lifetime history of greater than 10 blast exposures.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low-blast exposed control group</arm_group_label>
      <description>Participants in this group will have no history of traumatic brain injury AND will have a lifetime history of less than 10 blast exposures.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention. This is an observational study.</intervention_name>
      <description>There are no interventions being tested in the Cognitive and Vascular Functioning Following TBI study.</description>
      <arm_group_label>High-blast exposed control group</arm_group_label>
      <arm_group_label>Low-blast exposed control group</arm_group_label>
      <arm_group_label>TBI Group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood serum and plasma&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Male and female active duty service members or DEERS-eligible veterans at least 18 years of&#xD;
          age who have participated in the NICoE Intensive Outpatient Program or 15 Year Natural&#xD;
          History Study will be invited to participate.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Active duty uniformed SM or Veteran who is currently eligible for treatment at WRNMMC&#xD;
               (i.e., Defense Enrollment Eligibility Reporting System (DEERS)-eligible).&#xD;
  &#xD;
            2. Ability to read, write, and speak English.&#xD;
  &#xD;
            3. Ability to provide informed consent.&#xD;
  &#xD;
            4. NICoE Intensive Outpatient Program (IOP) or NatHx Study comprehensive evaluation ≥3&#xD;
               years prior to current evaluation with valid neuropsychological test results.&#xD;
  &#xD;
            5. Consent to allow access to prior research data collected through the NICoE TBI&#xD;
               Neuroimaging Core Project or NatHx Study and consent to allow access to at least 1&#xD;
               prior blood specimen previously collected through these studies or the DoD Serum&#xD;
               Biorepository.&#xD;
  &#xD;
          Additional TBI Inclusion Criteria&#xD;
  &#xD;
          1. History of at least one mild, moderate, severe, or penetrating TBI &gt; 3 years prior to&#xD;
          enrollment. TBI will be diagnosed if any one of the following criteria immediately after&#xD;
          the injury is met and attributed to the brain injury, rather than&#xD;
          environmental/psychological/other injury factors (DoD-VA criteria246):&#xD;
  &#xD;
            1. Loss of consciousness (LOC) or post-traumatic amnesia (PTA)&#xD;
  &#xD;
            2. Alteration of consciousness (AOC)&#xD;
  &#xD;
            3. Evidence of neurologic dysfunction&#xD;
  &#xD;
            4. TBI-related abnormality on structural neuroimaging (either CT or MRI). Additional&#xD;
               Healthy Control Criteria&#xD;
  &#xD;
                 1. History of military deployment.&#xD;
  &#xD;
                 2. Low history of blast exposure (i.e., &lt;10 blasts) Additional Blast Control&#xD;
                    Criteria&#xD;
  &#xD;
                 1. History of significant blast exposure (i.e., exposure to ≥ 10 blasts)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Disabling neurologic or psychological disorders such as autism, cerebral palsy,&#xD;
               developmental disorder, stroke, brain tumor, multiple sclerosis, meningitis,&#xD;
               encephalitis, brain abscess, vascular malformation, pre-injury epilepsy,&#xD;
               schizophrenia, bipolar disorder, personality disorder&#xD;
  &#xD;
            2. Diabetes mellitus requiring drug treatment&#xD;
  &#xD;
            3. Hypertension requiring more than 1 antihypertensive drug to control BP&#xD;
  &#xD;
            4. History of myocardial infarction or other systemic vasculopathies&#xD;
  &#xD;
            5. Dementia diagnosis at initial NICoE/NatHx Study assessment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Sara M Lippa, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Walter Reed National Military Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sara M Lippa, PhD</last_name>
      <phone>301-319-3671</phone>
      <email>sara.m.lippa.civ@health.mil</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Megan E Glazer, M.S.</last_name>
      <phone>301-295-5208</phone>
      <email>megan.e.glazer.ctr@health.mil</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Traumatic Brain Injury</keyword>
    <keyword>Cognitive Decline</keyword>
    <keyword>Vascular Dementia</keyword>
    <keyword>Blood Biomarkers</keyword>
    <keyword>Cerebrovascular Reactivity</keyword>
    <keyword>Military</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Dementia, Vascular</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Non-identified IPD will be made available through the Federal Interagency TBI Research (FITBIR) Database.</ipd_description>
      <ipd_time_frame>Data will be uploaded to the FITBIR system at the end of each funded year and at the completion of the study. This data will be made available to researchers using the FITBIR system 12 months after the end of the award period.</ipd_time_frame>
      <ipd_access_criteria>FITBIR qualified investigators will be provided access.</ipd_access_criteria>
      <ipd_url>http://fitbir.nih.gov/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034509
  org study id: WRNMMC-2022-0409
  secondary id: W81XWH-22-2
  nct id: NCT06034509
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational study will examine the association of chronic traumatic cerebrovascular
        injury and cardiovascular risk factors with TBI-related cognitive impairment and vascular
        dementia. Cerebrovascular, inflammatory, and neurodegenerative blood biomarkers as well as
        clinical and neuroimaging data
  The investigators will enroll 300 Service Members (SMs) and Veterans who participated in the
        National Intrepid Center of Excellence (NICoE) intensive outpatient program or Defense and
        Veterans Brain Injury Center/Traumatic Brain Injury Center of Excellence (DVBIC/TBICoE)
        15-Year TBI Natural History of TBI Study (NatHx) at least three years prior to the present
        evaluation and provided prior blood specimens stored for analysis. Following informed
        consent, participants will undergo semi-structured interviews assessing posttraumatic stress
        disorder (PTSD) and updated lifetime TBI history, neurological examination,
        neuropsychological testing, structural Magnetic Resonance Imaging (MRI) T1, T2, fluid
        attenuated inversion recovery (FLAIR), diffuse tensor imaging (DTI), as well as novel imaging
        techniques to assess imaging biomarkers of traumatic cerebrovascular injury (TCVI): 1)
        functional MRI (fMRI)-Blood Oxygen Level Dependent (BOLD) with hypercapnia challenge to
        measure cerebrovascular reactivity (CVR); and 2) Dynamic Contrast Enhanced-MRI to assess
        blood brain barrier integrity, and an additional research blood draw [apolipoprotein E (APOE)
        genotype; plasma biomarkers including vascular (e.g., vascular endothelial growth factor, von
        Willebrand Factor, cholesterol, homocysteine), inflammatory (e.g., high sensitivity
        c-reactive protein, interleukin-6 (IL-6), chitinase-3-like protein 1 (YKL-40)), and neuronal
        degeneration (e.g., neurofilament light, phosphorylated tau, brain-derived neurotrophic
        factor, beta amyloid proteins)]. A medical record review will be conducted specifically for
        current and past history of cerebrovascular risk factors (e.g., hypertension, diabetes,
        tobacco use) and psychological conditions (e.g., PTSD, depression). The project will also
        leverage previously collected data, comparing participants' symptoms, cognitive performance,
        imaging, and, blood biomarkers to those previously collected through the NICoE, 15-Year study
        and/or the DOD serum repository, with data from at least two time points on all individuals.
  observational model: Case-Control
  time perspective: Other
  measure: Panel of blood biomarkers
  time frame: 3 years
  description: A panel of blood biomarkers including vascular (e.g., vascular endothelial growth factor, von Willebrand Factor, cholesterol, lipoproteins, homocysteine, fibrinogen, hemoglobin A1C), inflammatory (e.g., high sensitivity c-reactive protein, Tumor Necrosis Factor-alpha, IL-6, IL-12p70, YKL-40), and neuronal degeneration (e.g., neurofilament light, Glial Fibrillary Acidic Protein, phosphorylated tau, Clusterin, brain-derived neurotrophic factor, beta amyloid proteins) will be compared between TBI groups. One-way ANOVAs will be run with TBI severity as the independent variable and each individual blood biomarker (measured in pg/mL) as the dependent variable. Spearman's rank order correlations will evaluate the relationship between blood biomarkers, number of TBIs, and TBI severity.
  measure: Cognitive Performance- Overall Test Battery Mean
  time frame: 3 years
  description: Neurocognitive data will be corrected for age, gender, education, and race, as available. An overall test battery mean (OTBM) T-score will be calculated as the average of seven cognitive domain T-scores (attention/processing speed, working memory, executive functioning, learning/immediate memory, delayed memory, language, perceptual reasoning). Each biomarker will be correlated with the OTBM using Spearman's rank order correlations. Cognitive domain T-scores will also be evaluated to understand which are driving changes in the OTBM. All scores will be evaluated as T-scores (mean=50, SD=10, min=0, max=100), for which higher scores indicate higher cognitive performance. Multivariable logistic regression will be used to evaluate the relationship between TBI number, TBI severity, blood biomarkers and normal cognition vs. mild cognitive impairment (MCI).
  measure: Change in panel of blood biomarkers over time
  time frame: 3 years
  description: Linear mixed effect (LME) models will be fit to the analysis dataset which use the panel of blood biomarkers as the response variables and investigate TBI severity, number of TBI events, and time. The panel of blood biomarkers will include vascular (e.g., vascular endothelial growth factor, von Willebrand Factor, cholesterol, lipoproteins, homocysteine, fibrinogen, hemoglobin A1C), inflammatory (e.g., high sensitivity c-reactive protein, Tumor Necrosis Factor-alpha, IL-6, IL-12p70, YKL-40), and neuronal degeneration (e.g., neurofilament light, Glial Fibrillary Acidic Protein, phosphorylated tau, Clusterin, brain-derived neurotrophic factor, beta amyloid proteins) biomarkers, all measured in pg/mL.
  measure: Change in overall test battery mean over time
  time frame: 3 years
  description: The investigators will fit a cross-sectional multivariable regression model to the data with the response variable being the change (Time 3 - Time 2) in the OTBM T-score (mean=50, SD=10, min=0, max=100). Individual cognitive domain composite T-scores will also be evaluated to understand the main components driving change in the OTBM.
  measure: Change in brain volume over time
  time frame: 3 years
  description: The investigators will fit a cross-sectional multivariable regression model to the data with the response variable being the change (Time 3 - Time 2) in total brain volume [milliliters (mL)].
  measure: Change in white matter lesions over time
  time frame: 3 years
  description: The investigators will fit a cross-sectional multivariable regression model to the data with the response variable being the change (Time 3 - Time 2) in total and total number of white matter lesions.
  measure: Cerebrovascular Reactivity
  time frame: 3 years
  description: Linear regression models will be run with the difference score in each vascular blood biomarker from the initial visit to the current study visit as the independent variable and global CVR (%S/mmHG) - (assessed during the current visit only) as the dependent variable.
  measure: DCE-MRI
  time frame: 3 years
  description: Linear regression models will be run with the difference score in each vascular blood biomarker from the initial visit to the current study visit as the independent variable and overall blood brain barrier function (assessed during the current visit only as the percentage of brain volume with suprathreshold voxels) as the dependent variable.
  arm group label: TBI Group
  description: Participants in this group will have been identified as sustaining a traumatic brain injury (mild, moderate, severe, or penetrating).
  arm group label: High-blast exposed control group
  description: Participants in this group will have no history of traumatic brain injury AND will have a lifetime history of greater than 10 blast exposures.
  arm group label: Low-blast exposed control group
  description: Participants in this group will have no history of traumatic brain injury AND will have a lifetime history of less than 10 blast exposures.
  intervention type: Other
  intervention name: No intervention. This is an observational study.
  description: There are no interventions being tested in the Cognitive and Vascular Functioning Following TBI study.
  arm group label: High-blast exposed control group
  arm group label: Low-blast exposed control group
  arm group label: TBI Group
  Blood serum and plasma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 74 Years
  last name: Sara M Lippa, PhD
  role: Principal Investigator
  affiliation: Walter Reed National Military Medical Center
  last name: Sara M Lippa, PhD
  phone: 301-319-3671
  email: sara.m.lippa.civ@health.mil
  last name: Megan E Glazer, M.S.
  phone: 301-295-5208
  email: megan.e.glazer.ctr@health.mil
  responsible party type: Sponsor
  mesh term: Dementia
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Dementia, Vascular
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: Non-identified IPD will be made available through the Federal Interagency TBI Research (FITBIR) Database.
  ipd time frame: Data will be uploaded to the FITBIR system at the end of each funded year and at the completion of the study. This data will be made available to researchers using the FITBIR system 12 months after the end of the award period.
  ipd access criteria: FITBIR qualified investigators will be provided access.
  ipd url: http://fitbir.nih.gov/