<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/NCT03794609</url>
  </required_header>
  <id_info>
    <org_study_id>TA46-002</org_study_id>
    <secondary_id>C4181001</secondary_id>
    <nct_id>NCT03794609</nct_id>
  </id_info>
  <brief_title>Observational Study Investigating Clinical &amp; Anthropometric Characteristics of Children With Achondroplasia.</brief_title>
  <official_title>An International, Prospective Registry Investigating the Natural History of Participants With Achondroplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</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 is a registry study in children with achondroplasia, age 0-10 years, to be conducted at&#xD;
      multiple clinical centers in several countries. Information collected will include in&#xD;
      anthropometric characteristics, related symptoms, tests, &amp; treatments&#xD;
&#xD;
      Children's information will be collected in the registry for a maximum of 5 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated on 18th November 2022. The decision to terminate the trial was not&#xD;
    based on any safety and/or efficacy concerns.&#xD;
  </why_stopped>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Actual">January 13, 2023</completion_date>
  <primary_completion_date type="Actual">January 13, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Collection of Natural History of Achondroplasia Characteristics in a cohort of Children aged 0-10 years old diagnosed with Achondroplasia</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>To quantify the number &amp; type of Achondroplasia Characteristics by review of medical records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collection of Natural History of Achondroplasia Symptoms in a cohort of Children aged 0-10 years old diagnosed with Achondroplasia</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>To quantify the number &amp; type of Achondroplasia Symptoms by review of medical records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collection of Natural History of Achondroplasia related Tests &amp; Treatments in a cohort of Children aged 0-10 years old diagnosed with Achondroplasia</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>To quantify the number &amp; type of Achondroplasia related Tests &amp; Treatments by review of medical records</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of biomarkers for bone growth</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
    <description>changes from Baseline in blood samples of collagen fragments</description>
  </secondary_outcome>
  <enrollment type="Actual">315</enrollment>
  <condition>Achondroplasia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        It is assumed that each of the study sites will enroll approximately 10-15 children of both&#xD;
        genders and of various ages (0-10 years old).&#xD;
&#xD;
        The total number of children planned to be enrolled across all sites is approximately 200.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent is obtained from the children's parent(s) / legal guardian(s)&#xD;
             before any study-related activity is carried out&#xD;
&#xD;
          2. The child is able to provide written informed assent, where this is required according&#xD;
             to national legislation, before any study related activity is carried out&#xD;
&#xD;
          3. The child has been diagnosed as having achondroplasia documented by clinical diagnosis&#xD;
&#xD;
          4. The child is between 0 years and 10 years of age, inclusive, on the date of consent /&#xD;
             assent&#xD;
&#xD;
          5. The investigator has considered the family and prospective participating child being&#xD;
             able to comply with the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The child has a diagnosis of hypochondroplasia or any short stature condition other&#xD;
             than achondroplasia (eg, spondyloepiphyseal dysplasia congenital [SEDC],&#xD;
             pseudoachondroplasia, trisomy 21)&#xD;
&#xD;
          2. The child has any medical condition that may impact growth or where the treatment is&#xD;
             known to impact growth, such as but not limited to hypothyroidism or hyperthyroidism,&#xD;
             insulin-requiring diabetes mellitus, autoimmune inflammatory disease (including celiac&#xD;
             disease, systemic lupus erythematosus [SLE], juvenile dermatomyositis, scleroderma,&#xD;
             and others), autonomic neuropathy, or inflammatory bowel disease&#xD;
&#xD;
          3. Treatment in the previous 12 months prior to consent and assent with growth hormone,&#xD;
             insulin-like growth factor 1 (IGF-1), anabolic steroids, or any other drug expected to&#xD;
             affect growth velocity&#xD;
&#xD;
          4. Any surgery that affects the growth plate of the long bones that is planned, or has&#xD;
             occurred in the past 18 months&#xD;
&#xD;
          5. Participation in any interventional study (investigational product or device) for&#xD;
             treatment of achondroplasia or short stature&#xD;
&#xD;
          6. Has had bone-related surgery impacting assessment of anthropometric measurements or is&#xD;
             expected to have it during the study period. Children with previous limb-lengthening&#xD;
             surgery may enroll if surgery occurred at least 18 months prior to the date of&#xD;
             consent/assent and healing is complete without sequelae as determined by the&#xD;
             investigator&#xD;
&#xD;
          7. Has any condition that in the view of the investigator places the child at high risk&#xD;
             of poor compliance with the visit schedule or of not completing the study.&#xD;
&#xD;
          8. Any concurrent disease or condition that in the view of the investigator would&#xD;
             interfere with study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Los Angeles Biomedical Research Institute At Harbour-UCLA Medical Centre</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred I. duPont Hospital for Children - Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>419803-3607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred I. duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>419803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The John Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Childrens Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univesity of Missouri - Columbia</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children'S Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Murdoch Childrens Research Institute</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital Melbourne</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Antwerp</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen (UZA)</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Children's Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Righospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Univesitaire La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Rare Skeletal Diseases in Childhood and Adolescence</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otto-von-Guericke- Universitat Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otto-von-Guericke-Universitat Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Lariana Como</name>
      <address>
        <city>San Fermo della Battaglia</city>
        <state>Como</state>
        <zip>22042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Giannina Gaslini</name>
      <address>
        <city>Genova</city>
        <state>Genoa</state>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Lariana Como</name>
      <address>
        <city>Como</city>
        <zip>22042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Giannina Gaslini</name>
      <address>
        <city>Genova</city>
        <zip>6147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Raffaele Hospital</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Rare Diseases, Department of Pediatrics, Polo Salute Donna e Bambino</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A.Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Women's and Children's Hospital</name>
      <address>
        <city>Izumi</city>
        <state>Osaka</state>
        <zip>594-1101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pediatrico de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-602</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pediátrico de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-602</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron University Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall D'Hebron Univeristy Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quironsalud Malaga</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS -CHUV Hôpital Neslé</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois -CHUV</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Childrens Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas NHS Trust, St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys &amp; St Thomas NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE1 3BZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Hospital NHS Foundation Trust</name>
      <address>
        <city>Newcastle</city>
        <zip>NE1 3BZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Children's NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Childrens NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=TA46-002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 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>Achondroplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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_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/NCT03794609
org study id: TA46-002
secondary id: C4181001
nct id: NCT03794609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at
      multiple clinical centers in several countries. Information collected will include in
      anthropometric characteristics, related symptoms, tests, & treatments

      Children's information will be collected in the registry for a maximum of 5 years.
observational model: Case-Only
time perspective: Prospective
measure: Collection of Natural History of Achondroplasia Characteristics in a cohort of Children aged 0-10 years old diagnosed with Achondroplasia
time frame: Up to 5 Years
description: To quantify the number & type of Achondroplasia Characteristics by review of medical records
measure: Collection of Natural History of Achondroplasia Symptoms in a cohort of Children aged 0-10 years old diagnosed with Achondroplasia
time frame: Up to 5 Years
description: To quantify the number & type of Achondroplasia Symptoms by review of medical records
measure: Collection of Natural History of Achondroplasia related Tests & Treatments in a cohort of Children aged 0-10 years old diagnosed with Achondroplasia
time frame: Up to 5 Years
description: To quantify the number & type of Achondroplasia related Tests & Treatments by review of medical records
measure: Measurement of biomarkers for bone growth
time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60
description: changes from Baseline in blood samples of collagen fragments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 15 Years
healthy volunteers: No
last name: Pfizer Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Australia
country: Belgium
country: Canada
country: China
country: Denmark
country: France
country: Germany
country: Italy
country: Japan
country: Portugal
country: Spain
country: Switzerland
country: United Kingdom
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=TA46-002
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Achondroplasia
sharing ipd: No
ipd 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.