<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/NCT04467918</url>
  </required_header>
  <id_info>
    <org_study_id>CANDIDATE study</org_study_id>
    <nct_id>NCT04467918</nct_id>
  </id_info>
  <brief_title>CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms</brief_title>
  <acronym>CANDIDATE</acronym>
  <official_title>Cannabidiol (CBD) in Patients With Mild to Moderate Symptoms of Coronavirus 2019: A Randomized, Double-blind, Placebo-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical&#xD;
      trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients&#xD;
      infected with SARS-CoV-2.&#xD;
&#xD;
      The specific objectives are to assess whether, in patients with mild and moderate forms of&#xD;
      SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of:&#xD;
&#xD;
      i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from&#xD;
      serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv)&#xD;
      improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor&#xD;
      the possible adverse effects of CBD use in these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study will be a single-center, randomized, parallel, double-blind,&#xD;
      placebo-controlled clinical trial of CBD in patients with mild to moderate SARS-CoV-2&#xD;
      infection. The investigators will use random stratification by minimizing the sample to&#xD;
      stratify all eligible patients according to gender, age, disease severity (mild or moderate)&#xD;
      and presence of comorbidity (controlled diabetes and/or hypertension), followed by random&#xD;
      designation (in a ratio 1: 1) in each stratum to ensure a balanced distribution of disease&#xD;
      severity among treatment groups (CBD plus symptomatic clinical and pharmacological measures)&#xD;
      and control (symptomatic clinical and pharmacological measures and placebo). All patients&#xD;
      will receive the clinical and pharmacological measures standardized by the Brazilian Ministry&#xD;
      of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for&#xD;
      SARS-CoV-2 (https://portalarquivos.saude.gov.br/images/pdf&#xD;
      /2020/April/18/Dirursos-Covid19.pdf). In other words, the following pharmacological measures:&#xD;
      &quot;prescription of drugs for symptom control, if there is no contraindication, with the&#xD;
      possibility of intercalating antipyretic drugs in cases of difficult control of fever. • Oral&#xD;
      antipyretic: 1st option: Paracetamol 500-1000 mg/dose (maximum 3mg / day) • 2nd option:&#xD;
      Dipyrone 500-1000 mg VO (maximum dose in adults 4 grams)&quot;, and clinical measures:&quot; Home&#xD;
      isolation by 14 days from the date of onset of symptoms; review every 48 hours, preferably by&#xD;
      phone, providing face-to-face assistance, if necessary; maintain rest, a balanced diet and a&#xD;
      good supply of fluids; isolation from home contacts for 14 days&quot;.&#xD;
&#xD;
      Thus, all patients will receive clinical and pharmacological measures of symptoms. Patients&#xD;
      in the investigational treatment group will also receive CBD within 24 hours after&#xD;
      randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for&#xD;
      14 days. Patients in the placebo group will also receive, within 24 hours after&#xD;
      randomization, 1mL of the same investigational medication vehicle (medium/coconut chain&#xD;
      triglyceride oil - MCT) for 14 days, using a dosing device/syringe indistinguishable from the&#xD;
      CBD medication. Patients, nursing staff, laboratory technicians, doctors who will carry out&#xD;
      the assessments, researchers, and statisticians will be blind to the treatment group and will&#xD;
      not know about the treatment information.&#xD;
&#xD;
      Secretions from the upper respiratory tract, lower respiratory tract, or both, by swab, will&#xD;
      be obtained from each patient in the screening (day -3 to day 1) during treatment and&#xD;
      post-treatment follow-up at the patient's home on days 1, 2, 3, 4, 5, 7, 10, 14, 21, and 28,&#xD;
      to test the viral load and SARS-CoV-2 genotyping. On all these dates, nurses will visit home&#xD;
      to collect swab (only from the oropharynx, to minimize discomfort), blood and will be&#xD;
      evaluated at each visit for vital signs, pulse oximetry, odor test, and treatment guidelines.&#xD;
      Each patient will also receive a digital thermometer to measure the axillary temperature in&#xD;
      case of suspected fever and daily measurement immediately before lunch and dinner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">November 16, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 16, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A total of 104 patients with SARS-CoV-2 infection will be included in the study (i.e., 52 cases in the CBD group plus pharmacological and clinical measures and 52 in the placebo group plus pharmacological and clinical measures). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of severe/critical stage of Covid19</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Deterioration in clinical status from mild/moderate to severe/critical over time during the study period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Clinical CoVid19 symptoms Clinical improvement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in proinflammatory cytokine concentration</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Immune reaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT</measure>
    <time_frame>14 days</time_frame>
    <description>A qualitative CT analysis of parenchymal lung damage induced by COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Time to clinical improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that need hospitalisation</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>CoVid severity worsening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to positive-to-negative saliva 2019-n-CoV RT-PCR conversion</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Time to negative saliva</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in viral load</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Mean reduction in viral load (reduction of ≥1 log10) over time during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief measure for assessing generalized anxiety disorder and depression</measure>
    <time_frame>Through study completion, over time during the study period (day 0-28)]</time_frame>
    <description>Brief measure for assessing generalized anxiety disorder (The GAD-7) and depression (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increment of odor detection sensitivity</measure>
    <time_frame>Through study completion, over time during the study period (day 0-28)]</time_frame>
    <description>Scores of the brief peanut butter olfactory test (Univ Florida)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>SARS-CoV2</condition>
  <arm_group>
    <arm_group_label>Cannabidiol (CBD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 cases in the CBD group plus pharmacological and clinical measures. Patients in the investigational treatment group will receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (PLB)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>50 in the placebo group plus pharmacological and clinical measures. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium / coconut chain triglyceride oil - MCT) for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabidiol</intervention_name>
    <description>Already described</description>
    <arm_group_label>Cannabidiol (CBD)</arm_group_label>
    <other_name>CBD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PLACEBO</intervention_name>
    <description>Already described</description>
    <arm_group_label>Placebo (PLB)</arm_group_label>
    <other_name>PLB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of both sexes, older than 18 years of age, with SARS-CoV-2 infection&#xD;
             confirmed in upper or lower respiratory tract secretion, through reverse transcription&#xD;
             followed by polymerase chain reaction (RT- PCR), with mild or moderate manifestations&#xD;
             of Covid-19, who wish to participate, and consent by signing the informed consent form&#xD;
             and not involved in another clinical trial during the study period&#xD;
&#xD;
          2. Pneumonia assessed clinically and / or radiologically will not be mandatory for&#xD;
             inclusion&#xD;
&#xD;
          3. Have a telephone (cellular or landline) that may be available to receive daily calls&#xD;
             throughout the study period.&#xD;
&#xD;
          4. Willingness to voluntarily participate in the study to accept randomization for either&#xD;
             treatment arm.&#xD;
&#xD;
          5. Signing of the approved Free and Informed Consent Form (ICF) by the Research Ethics&#xD;
             Committee (CEP) and CONEP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age below 18 years&#xD;
&#xD;
          2. Patients who do not want or can fulfill the necessary home isolation for at least 14&#xD;
             days&#xD;
&#xD;
          3. Chronic clinical conditions, severe or not compensated, such as: insulin-dependent&#xD;
             diabetes (types 1 or 2); uncontrolled hypertension, lung disease such as asthma or&#xD;
             COPD; hematological and liver diseases, chronic kidney disease in advanced stage&#xD;
             (grades 3, 4 and 5), metabolic disorders and immunosuppression&#xD;
&#xD;
          4. Use of any medication with potential interaction with CBD (such as chloroquine,&#xD;
             clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the&#xD;
             use of this cannabinoid&#xD;
&#xD;
          5. Inability to use oral medication&#xD;
&#xD;
          6. Pregnancy or lactation&#xD;
&#xD;
          7. History of alcohol or drug addiction&#xD;
&#xD;
          8. Smoking in the last three years&#xD;
&#xD;
          9. Marijuana use in the last three months&#xD;
&#xD;
         10. Inability to cooperate with researchers due to cognitive impairment or mental state&#xD;
&#xD;
         11. Patients with severe forms of SARS-CoV-2, (on screening, inclusion or initial visit)&#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>Jose ALEXANDRE DE S CRIPPA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Serviço de Assistência Médica e Social do Pessoal do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>SP</state>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade de Pronto Atendimento/UPA - 13 de Maio/Dr. Luis Atílio Losi Viana (UPA Covid)</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14090-270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Jose Alexandre de Souza Crippa</investigator_full_name>
    <investigator_title>Professor of Psychiatry, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV2; Cannabidiol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Immediately the following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal. Depending on the level of the proposed use of data, approval by an independent review committee will be required for the identified purpose.</ipd_access_criteria>
  </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/NCT04467918
org study id: CANDIDATE study
nct id: NCT04467918
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical
      trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients
      infected with SARS-CoV-2.

      The specific objectives are to assess whether, in patients with mild and moderate forms of
      SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of:

      i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from
      serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv)
      improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor
      the possible adverse effects of CBD use in these patients.
The present study will be a single-center, randomized, parallel, double-blind,
      placebo-controlled clinical trial of CBD in patients with mild to moderate SARS-CoV-2
      infection. The investigators will use random stratification by minimizing the sample to
      stratify all eligible patients according to gender, age, disease severity (mild or moderate)
      and presence of comorbidity (controlled diabetes and/or hypertension), followed by random
      designation (in a ratio 1: 1) in each stratum to ensure a balanced distribution of disease
      severity among treatment groups (CBD plus symptomatic clinical and pharmacological measures)
      and control (symptomatic clinical and pharmacological measures and placebo). All patients
      will receive the clinical and pharmacological measures standardized by the Brazilian Ministry
      of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for
      SARS-CoV-2 (https://portalarquivos.saude.gov.br/images/pdf
      /2020/April/18/Dirursos-Covid19.pdf). In other words, the following pharmacological measures:
      "prescription of drugs for symptom control, if there is no contraindication, with the
      possibility of intercalating antipyretic drugs in cases of difficult control of fever. • Oral
      antipyretic: 1st option: Paracetamol 500-1000 mg/dose (maximum 3mg / day) • 2nd option:
      Dipyrone 500-1000 mg VO (maximum dose in adults 4 grams)", and clinical measures:" Home
      isolation by 14 days from the date of onset of symptoms; review every 48 hours, preferably by
      phone, providing face-to-face assistance, if necessary; maintain rest, a balanced diet and a
      good supply of fluids; isolation from home contacts for 14 days".

      Thus, all patients will receive clinical and pharmacological measures of symptoms. Patients
      in the investigational treatment group will also receive CBD within 24 hours after
      randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for
      14 days. Patients in the placebo group will also receive, within 24 hours after
      randomization, 1mL of the same investigational medication vehicle (medium/coconut chain
      triglyceride oil - MCT) for 14 days, using a dosing device/syringe indistinguishable from the
      CBD medication. Patients, nursing staff, laboratory technicians, doctors who will carry out
      the assessments, researchers, and statisticians will be blind to the treatment group and will
      not know about the treatment information.

      Secretions from the upper respiratory tract, lower respiratory tract, or both, by swab, will
      be obtained from each patient in the screening (day -3 to day 1) during treatment and
      post-treatment follow-up at the patient's home on days 1, 2, 3, 4, 5, 7, 10, 14, 21, and 28,
      to test the viral load and SARS-CoV-2 genotyping. On all these dates, nurses will visit home
      to collect swab (only from the oropharynx, to minimize discomfort), blood and will be
      evaluated at each visit for vital signs, pulse oximetry, odor test, and treatment guidelines.
      Each patient will also receive a digital thermometer to measure the axillary temperature in
      case of suspected fever and daily measurement immediately before lunch and dinner.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 104 patients with SARS-CoV-2 infection will be included in the study (i.e., 52 cases in the CBD group plus pharmacological and clinical measures and 52 in the placebo group plus pharmacological and clinical measures). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Prevention of severe/critical stage of Covid19
time frame: Up to 28 days
description: Deterioration in clinical status from mild/moderate to severe/critical over time during the study period
measure: Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0
time frame: Up to 28 days
description: Clinical CoVid19 symptoms Clinical improvement
measure: Change in proinflammatory cytokine concentration
time frame: Up to 28 days
description: Immune reaction
measure: Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT
time frame: 14 days
description: A qualitative CT analysis of parenchymal lung damage induced by COVID-19
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
time frame: Up to 28 days
description: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measure: Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0
time frame: Up to 28 days
description: Time to clinical improvement
measure: Number of participants that need hospitalisation
time frame: Up to 28 days
description: CoVid severity worsening
measure: 28-day mortality
time frame: Up to 28 days
description: Mortality
measure: Time to positive-to-negative saliva 2019-n-CoV RT-PCR conversion
time frame: Up to 28 days
description: Time to negative saliva
measure: Reduction in viral load
time frame: Up to 28 days
description: Mean reduction in viral load (reduction of ≥1 log10) over time during the study period
measure: Brief measure for assessing generalized anxiety disorder and depression
time frame: Through study completion, over time during the study period (day 0-28)]
description: Brief measure for assessing generalized anxiety disorder (The GAD-7) and depression (PHQ-9)
measure: Increment of odor detection sensitivity
time frame: Through study completion, over time during the study period (day 0-28)]
description: Scores of the brief peanut butter olfactory test (Univ Florida)
arm group label: Cannabidiol (CBD)
arm group type: Experimental
description: 50 cases in the CBD group plus pharmacological and clinical measures. Patients in the investigational treatment group will receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days.
arm group label: Placebo (PLB)
arm group type: Placebo Comparator
description: 50 in the placebo group plus pharmacological and clinical measures. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium / coconut chain triglyceride oil - MCT) for 14 days
intervention type: Drug
intervention name: Cannabidiol
description: Already described
arm group label: Cannabidiol (CBD)
other name: CBD
intervention type: Other
intervention name: PLACEBO
description: Already described
arm group label: Placebo (PLB)
other name: PLB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose ALEXANDRE DE S CRIPPA, MD, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Jose Alexandre de Souza Crippa
investigator title: Professor of Psychiatry, MD, PhD
mesh term: Cannabidiol
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Immediately the following publication. No end date.
ipd access criteria: Researchers who provide a methodologically sound proposal. Depending on the level of the proposed use of data, approval by an independent review committee will be required for the identified purpose.