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/NCT06011837</url>
    </required_header>
    <id_info>
      <org_study_id>1906848293</org_study_id>
      <nct_id>NCT06011837</nct_id>
    </id_info>
    <brief_title>Effects of Altered Auditory Feedback on Speech Fluency</brief_title>
    <official_title>Effects of Altered Auditory Feedback on Speech Fluency</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts Institute of Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts Institute of Technology</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to use altered auditory vocal feedback to increase fluency in&#xD;
        people who stutter and to examine changes in this effect over the course of a one month&#xD;
        period occurring outside the laboratory setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Mumble Melody app applies voice transformations (or &quot;modes&quot;) to a user's voice in&#xD;
        real-time while they are speaking. The modes include Unaltered, Whisper, Reverberated, and&#xD;
        Harmonious voice transformations. The Mumble Melody Longitudinal Study is a month-long online&#xD;
        study in which we will be investigating the longer term effects of using the Mumble Melody&#xD;
        app for people who stutter. During the course of a month, eligible participants will use the&#xD;
        Mumble Melody app daily for however long, on whichever modes, and in whichever settings they&#xD;
        wish. Additionally, we will be sending an online platform for participants to conduct weekly&#xD;
        at-home testing sessions, in which they will be asked to record their voice during various&#xD;
        speech tasks, both with and without the Mumble Melody app. During testing sessions, we will&#xD;
        collect voice recordings from participants.&#xD;
  &#xD;
        Step 1: Participants will sign a consent form via Redcap. Participants will need an Apple&#xD;
        device compatible with the Mumble Melody app.&#xD;
  &#xD;
        Step 2: Participants will receive an additional form via Redcap through which they can input&#xD;
        information about what device they will be using for the Mumble Melody study, as well as&#xD;
        shipping information to receive wired headphones and a headphone jack (which are necessary to&#xD;
        use the app).&#xD;
  &#xD;
        Step 3: Participants conduct an initial screening session through an online platform, in&#xD;
        which they respond to 3 90-second open questions and conduct a passage reading task. We will&#xD;
        be collecting voice recordings as they speak within the sessions.&#xD;
  &#xD;
        Step 4: Participants' eligibility will be determined using the voice recordings received from&#xD;
        step 3. The amount of stuttering-like events and total number of syllables within the&#xD;
        recordings will determine if participants have a moderate to severe stutter, meaning they&#xD;
        will be eligible for the study.&#xD;
  &#xD;
        Step 5: Eligible participants are shipped wired headphones and a headphone jack adapter&#xD;
  &#xD;
        Step 6: Participants will fill out an initial survey and optional OASES (Overall Assessment&#xD;
        of the Speaker's Experience of Stuttering) assessment of through an online platform.&#xD;
  &#xD;
        Step 7: Participants conduct a baseline testing session. During this testing session,&#xD;
        participants will answer survey questions, record answers to 2 90-second open response&#xD;
        questions without using the Mumble Melody app, follow a step-by-step guide to download and&#xD;
        set up the Mumble Melody app, record answers to 2 90-second open response for each of the 4&#xD;
        modes on the Mumble Melody app, and finally record answers to 2 90-second open response&#xD;
        questions without using the Mumble Melody app.&#xD;
  &#xD;
        Step 8: Step 8: For the following 28 days, participants will be told to use the app as they&#xD;
        wish. We will collect app usage logs, which provide timestamps indicating which mode was used&#xD;
        and length of use. Participants will receive an additional monetary reward if they use the&#xD;
        app for at least 5 minutes for 4 out of 6 days each week.&#xD;
  &#xD;
        Step 9: Participants conduct 4 testing sessions, one at the end of each week of the study&#xD;
        (day 8, 15, 22, and 29). During each testing session, participants will answer survey&#xD;
        questions, record answers to 2 90-second open response questions without using the Mumble&#xD;
        Melody app, record answers to 2 90-second open response for each of the 4 modes on the Mumble&#xD;
        Melody app, and finally record answers to 2 90-second open response questions without using&#xD;
        the Mumble Melody app.&#xD;
  &#xD;
        Step 10: After the study, participants will be sent a final survey asking questions on their&#xD;
        experience throughout the study and their feedback for the app.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 26, 2023</start_date>
    <completion_date type="Anticipated">July 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 14, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and the end of week 4.</measure>
      <time_frame>Calculated at the end of the study for time points 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Baseline - Week 4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency of Mode Usage</measure>
      <time_frame>Calculated every day for 4 weeks</time_frame>
      <description>Number of times participants use each modes per day throughout the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Mode Usage</measure>
      <time_frame>Calculated every day for 4 weeks</time_frame>
      <description>Length of times participants use different modes per day throughout the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survey data on experience using the application</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>A final survey provided for participants' feedback on their experience</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and end of week 1, 2, and 3.</measure>
      <time_frame>Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Baseline - Week 1,2,3 Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant change in fluency in the Baseline (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.</measure>
      <time_frame>Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant change in fluency in the Final (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.</measure>
      <time_frame>Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant change in fluency for the Final (No Auditory Feedback) condition in comparison to the baseline (No Auditory Feedback) condition, for each testing session</measure>
      <time_frame>Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Baseline (No Auditory Feedback) - Final (No Auditory Feedback) for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant change in fluency for each mode in comparison to the baseline (No Auditory Feedback) condition, for each testing session</measure>
      <time_frame>Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Baseline (No Auditory Feedback) - each Mode for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant change in fluency for each non- control mode (Whisper, Reverb, Harmonize) in comparison to the control mode (Unaltered), for each testing session</measure>
      <time_frame>Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Fluency change From Unaltered Mode - Whisper/Reverb/Harmonize modes for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Stuttering, Adult</condition>
    <arm_group>
      <arm_group_label>Altered Auditory Feedback</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this arm will use the Mumble Melody application over the course of 1 month</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Altered Auditory Feedback</intervention_name>
      <description>Mumble Melody is an application that leverages Altered Auditory Feedback (AAF). During AAF, a person's speech is altered in near-real time. Mumble Melody modulates the user's voice and plays it back to them while they are speaking. Included are Unaltered (raw voice), Whisper (voiceless sound), Reverb (cathedral sound), and Harmonized (robotic sound) voice transformations.</description>
      <arm_group_label>Altered Auditory Feedback</arm_group_label>
      <other_name>Musically Modulated Auditory Feedback</other_name>
      <other_name>Mumble Melody</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Identifies as a person who stutters&#xD;
  &#xD;
            -  Is US citizen or green card holder currently residing in the US&#xD;
  &#xD;
            -  Has one of the following Apple devices:&#xD;
  &#xD;
            -  iPhone with iOS 12.0 or later&#xD;
  &#xD;
            -  iPad with iPadOS 12.0 or later&#xD;
  &#xD;
            -  iPod touch with iOS 12.0 or later&#xD;
  &#xD;
            -  Mac with macOS 11.0 or later and an Apple M1 chip or later&#xD;
  &#xD;
            -  Has a SEPARATE browser-supporting device with a microphone&#xD;
  &#xD;
            -  Is able to conduct the study in English&#xD;
  &#xD;
            -  Qualifies based on an initial screening evaluation (Greater than 2.5% Stuttering-Like&#xD;
               Dysfluencies per syllable)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Satrajit Ghosh, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts Institute of Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alisha Kodibagkar, MS</last_name>
      <phone>2145973346</phone>
      <email>akodiba1@mit.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca Kleinberger, PhD</last_name>
      <email>rebklein@mit.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Massachusetts Institute of Technology</name>
        <address>
          <city>Cambridge</city>
          <state>Massachusetts</state>
          <zip>02139</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alisha Kodibagkar, MS</last_name>
        <phone>214-597-3346</phone>
        <email>akodiba1@mit.edu</email>
      </contact>
      <contact_backup>
        <last_name>Rebecca Kleinberger, PhD</last_name>
        <email>rebklein@mit.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Satrajit Ghosh, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>Stuttering</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Subjects can choose to consent to having their audio recordings and survey answers shared with the researchers of this study and other qualified researchers.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Starting September 2024</ipd_time_frame>
      <ipd_access_criteria>The data will be shared through an online repository such as Dataverse, with associated data use agreement to not use the information to identify participants, and to reuse the data in a manner to verify the outcomes of the research or related research. Based on our consent form, individual data may also be submitted to databases for any broad reuse.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT06011837/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>May 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT06011837/SAP_001.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT06011837/ICF_002.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06011837
  org study id: 1906848293
  nct id: NCT06011837
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The purpose of the study is to use altered auditory vocal feedback to increase fluency in
        people who stutter and to examine changes in this effect over the course of a one month
        period occurring outside the laboratory setting.
  The Mumble Melody app applies voice transformations (or "modes") to a user's voice in
        real-time while they are speaking. The modes include Unaltered, Whisper, Reverberated, and
        Harmonious voice transformations. The Mumble Melody Longitudinal Study is a month-long online
        study in which we will be investigating the longer term effects of using the Mumble Melody
        app for people who stutter. During the course of a month, eligible participants will use the
        Mumble Melody app daily for however long, on whichever modes, and in whichever settings they
        wish. Additionally, we will be sending an online platform for participants to conduct weekly
        at-home testing sessions, in which they will be asked to record their voice during various
        speech tasks, both with and without the Mumble Melody app. During testing sessions, we will
        collect voice recordings from participants.
  
        Step 1: Participants will sign a consent form via Redcap. Participants will need an Apple
        device compatible with the Mumble Melody app.
  
        Step 2: Participants will receive an additional form via Redcap through which they can input
        information about what device they will be using for the Mumble Melody study, as well as
        shipping information to receive wired headphones and a headphone jack (which are necessary to
        use the app).
  
        Step 3: Participants conduct an initial screening session through an online platform, in
        which they respond to 3 90-second open questions and conduct a passage reading task. We will
        be collecting voice recordings as they speak within the sessions.
  
        Step 4: Participants' eligibility will be determined using the voice recordings received from
        step 3. The amount of stuttering-like events and total number of syllables within the
        recordings will determine if participants have a moderate to severe stutter, meaning they
        will be eligible for the study.
  
        Step 5: Eligible participants are shipped wired headphones and a headphone jack adapter
  
        Step 6: Participants will fill out an initial survey and optional OASES (Overall Assessment
        of the Speaker's Experience of Stuttering) assessment of through an online platform.
  
        Step 7: Participants conduct a baseline testing session. During this testing session,
        participants will answer survey questions, record answers to 2 90-second open response
        questions without using the Mumble Melody app, follow a step-by-step guide to download and
        set up the Mumble Melody app, record answers to 2 90-second open response for each of the 4
        modes on the Mumble Melody app, and finally record answers to 2 90-second open response
        questions without using the Mumble Melody app.
  
        Step 8: Step 8: For the following 28 days, participants will be told to use the app as they
        wish. We will collect app usage logs, which provide timestamps indicating which mode was used
        and length of use. Participants will receive an additional monetary reward if they use the
        app for at least 5 minutes for 4 out of 6 days each week.
  
        Step 9: Participants conduct 4 testing sessions, one at the end of each week of the study
        (day 8, 15, 22, and 29). During each testing session, participants will answer survey
        questions, record answers to 2 90-second open response questions without using the Mumble
        Melody app, record answers to 2 90-second open response for each of the 4 modes on the Mumble
        Melody app, and finally record answers to 2 90-second open response questions without using
        the Mumble Melody app.
  
        Step 10: After the study, participants will be sent a final survey asking questions on their
        experience throughout the study and their feedback for the app.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and the end of week 4.
  time frame: Calculated at the end of the study for time points 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Baseline - Week 4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  measure: Frequency of Mode Usage
  time frame: Calculated every day for 4 weeks
  description: Number of times participants use each modes per day throughout the study
  measure: Duration of Mode Usage
  time frame: Calculated every day for 4 weeks
  description: Length of times participants use different modes per day throughout the study
  measure: Survey data on experience using the application
  time frame: immediately after the intervention
  description: A final survey provided for participants' feedback on their experience
  measure: Significant change in fluency in one of four modes (Unaltered, Whisper, Reverb, Harmonize) between the baseline testing session and end of week 1, 2, and 3.
  time frame: Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Baseline - Week 1,2,3 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  measure: Significant change in fluency in the Baseline (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.
  time frame: Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  measure: Significant change in fluency in the Final (No Auditory Feedback) condition between baseline and end of week 1, 2, 3, and 4.
  time frame: Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Baseline - Week 1,2,3,4 Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  measure: Significant change in fluency for the Final (No Auditory Feedback) condition in comparison to the baseline (No Auditory Feedback) condition, for each testing session
  time frame: Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Baseline (No Auditory Feedback) - Final (No Auditory Feedback) for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  measure: Significant change in fluency for each mode in comparison to the baseline (No Auditory Feedback) condition, for each testing session
  time frame: Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Baseline (No Auditory Feedback) - each Mode for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  measure: Significant change in fluency for each non- control mode (Whisper, Reverb, Harmonize) in comparison to the control mode (Unaltered), for each testing session
  time frame: Calculated at the end of the study for time points: Baseline, 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Fluency change From Unaltered Mode - Whisper/Reverb/Harmonize modes for each Testing Session Measured by Stuttering-Like Dysfluencies within voice recordings from participants
  arm group label: Altered Auditory Feedback
  arm group type: Experimental
  description: Participants in this arm will use the Mumble Melody application over the course of 1 month
  intervention type: Device
  intervention name: Altered Auditory Feedback
  description: Mumble Melody is an application that leverages Altered Auditory Feedback (AAF). During AAF, a person's speech is altered in near-real time. Mumble Melody modulates the user's voice and plays it back to them while they are speaking. Included are Unaltered (raw voice), Whisper (voiceless sound), Reverb (cathedral sound), and Harmonized (robotic sound) voice transformations.
  arm group label: Altered Auditory Feedback
  other name: Musically Modulated Auditory Feedback
  other name: Mumble Melody
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Satrajit Ghosh, PhD
  role: Principal Investigator
  affiliation: Massachusetts Institute of Technology
  last name: Alisha Kodibagkar, MS
  phone: 2145973346
  email: akodiba1@mit.edu
  last name: Rebecca Kleinberger, PhD
  email: rebklein@mit.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stuttering
  sharing ipd: Yes
  ipd description: Subjects can choose to consent to having their audio recordings and survey answers shared with the researchers of this study and other qualified researchers.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Starting September 2024
  ipd access criteria: The data will be shared through an online repository such as Dataverse, with associated data use agreement to not use the information to identify participants, and to reuse the data in a manner to verify the outcomes of the research or related research. Based on our consent form, individual data may also be submitted to databases for any broad reuse.
  provided document: 
  provided document: 
  provided document: 