<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/NCT03793881</url>
  </required_header>
  <id_info>
    <org_study_id>NUPRESS</org_study_id>
    <nct_id>NCT03793881</nct_id>
  </id_info>
  <brief_title>Nutritional Strategy for Blood Pressure Control in Patients With Hypertension (NUPRESS)</brief_title>
  <official_title>Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System: NUPRESS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital do Coracao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital do Coracao</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>
      Adherence to a healthy dietary pattern is part of the self-care of patients with&#xD;
      hypertension, and may contribute substantially to therapeutic target goals as well as to a&#xD;
      better quality of life. However, not all nutritional recommendations aimed at these patients&#xD;
      are easily applicable in clinical practice. The primary objective of the study is to evaluate&#xD;
      the effectiveness of a nutritional strategy for blood pressure control in patients with&#xD;
      hypertension users of a Public Health System after 6 months of follow-up. As secondary&#xD;
      objectives, we will evaluate the impact of the proposed strategy on self-care and on the&#xD;
      quality of life of the patients. In this multicenter open-label randomized trial, 408&#xD;
      patients ≥21 years old with hypertension, systolic blood pressure (SBP) ≥140mmHg at the&#xD;
      moment of the screening and who have not received or received nutritional counseling for at&#xD;
      least 06 months will be enrolled. Patients allocated to the control group will receive&#xD;
      individualized dietary prescription according to the guidelines of the Brazilian Society of&#xD;
      Cardiology. Nutritional counseling in the intervention group will be performed based on the&#xD;
      quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness&#xD;
      and mindful eating; all dietary guidance will be based on feasible goals built together&#xD;
      (patient and nutritionist), and no diet will be prescribed for intervention group. In both&#xD;
      groups, patients will receive automatic monitors for residential self-monitoring blood&#xD;
      pressure. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final&#xD;
      consultation). At 120 and 150 days, participants in the intervention group will receive&#xD;
      motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be&#xD;
      a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum&#xD;
      sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed&#xD;
      at baseline and 180 days; anthropometric indexes and diastolic blood pressure (DBP) will be&#xD;
      also evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2019</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 22, 2021</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SBP</measure>
    <time_frame>6 months</time_frame>
    <description>Systolic blood pressure, in mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BPC</measure>
    <time_frame>6 months</time_frame>
    <description>Blood pressure control, defined as either having systolic blood pressure (SBP) &gt; 140 mmHg at baseline and achieving SBP ≤ 140 mmHg after follow-up or having SBP ≤ 140 mmHg at baseline and reducing anti-hypertensive drugs after follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DBP</measure>
    <time_frame>6 months</time_frame>
    <description>Diastolic blood pressure, in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>6 months</time_frame>
    <description>Glycated hemoglobin, in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FG</measure>
    <time_frame>6 months</time_frame>
    <description>Fasting glucose, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BW</measure>
    <time_frame>6 months</time_frame>
    <description>Body weight, in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WC</measure>
    <time_frame>6 months</time_frame>
    <description>Waist circumference, in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>6 months</time_frame>
    <description>Body mass index, in kg/m2; it will be defined according to the mathematical formula (BW/height*height)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TC</measure>
    <time_frame>6 months</time_frame>
    <description>Total cholesterol, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-c</measure>
    <time_frame>6 months</time_frame>
    <description>LDL cholesterol, in mg/dL; it will be defined according to the Martin´s mathematical formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-c</measure>
    <time_frame>6 months</time_frame>
    <description>HDL cholesterol, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TG</measure>
    <time_frame>6 months</time_frame>
    <description>Serum triglycerides, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VLDL-c</measure>
    <time_frame>6 months</time_frame>
    <description>VLDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TG/5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NHDL</measure>
    <time_frame>6 months</time_frame>
    <description>Non-HDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TC-HDL-c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Castelli Index I</measure>
    <time_frame>6 months</time_frame>
    <description>Castelli Index I, in mg/dL; it will be obtained according to the mathematical formula TC/HDL-c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Castelli Index II</measure>
    <time_frame>6 months</time_frame>
    <description>Castelli Index II, in mg/dL; it will be obtained according to the mathematical formula LDL-c/HDL-c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cr</measure>
    <time_frame>6 months</time_frame>
    <description>Creatinine, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GFR</measure>
    <time_frame>6 months</time_frame>
    <description>Glomerular filtration rate, in ml/min/1.73m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium (s)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum sodium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium (u)</measure>
    <time_frame>6 months</time_frame>
    <description>Urinary sodium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium (s)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum potassium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium (u)</measure>
    <time_frame>6 months</time_frame>
    <description>Urinary potassium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALB</measure>
    <time_frame>6 months</time_frame>
    <description>Albuminuria, in mg/g</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DQ</measure>
    <time_frame>6 months</time_frame>
    <description>Diet quality, assessed by the modified Alternative Healthy Eating Index (mAHEI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MINICHAL</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life evaluated by the Brazilian version of the Mini-cuestionario de calidad de vida en la hipertensión arterial. In this tool, ten items are related to the &quot;mental status&quot; domain and six items to &quot;somatic manifestations&quot;. Questions refer to the past seven days. The score scale is a likert-type scale with four possible answers (0=absolutely no; 1=yes, a little; 2=yes, fairly; 3=yes, a lot). The points range from 0 (best health level) to 30 (worst health level) for the &quot;mental status&quot; dimension, and from 0 (best health level) to 18 (worst health level) for the &quot;somatic manifestations&quot; dimension.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SHIQ</measure>
    <time_frame>6 months</time_frame>
    <description>Self-care evaluated by the Brazilian version of the Self-care of Hypertension Inventory Questionaire. This tool includes 23 items divided across 3 scales: Self-care Maintenance (11 items), Self-care Management (6 items), and Self-care Confidence (6 items). Items in the instrument are scored on a Likert-type scale. In the Self-care Maintenance domain, scores range from 1 to 5 (''never'' to ''always''). In the Self-care Management domain, 2 items range from 0 to 5 to capture a fully negative response, and other item options are scored 1 to 5. The remaining items are scored from 1 to 5 (''not likely'' to ''very likely''). In the self-care confidence scale, items are scored from 1 to 5. Scores are calculated for each scale individually. Each scale is standardized to range from 0 to 100. Self-care is considered adequate if the score is 70 or greater.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>TT</measure>
    <time_frame>6 months</time_frame>
    <description>Therapeutic targets, defined as the proportion of participants who reached the following therapeutic targets: SBP/DBP &lt; 140/90 mmHg; fasting glucose &lt;100 mg/dL; LDL-c &lt;100 mg/dL; BMI &lt; 25 kg/m2 or weight loss &gt; 5%</description>
  </other_outcome>
  <other_outcome>
    <measure>AHD</measure>
    <time_frame>6 months</time_frame>
    <description>Anti-hypertensive drugs, defined as the type and proportion of anti-hypertensive drugs used</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">408</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Nutritional Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary Prescription</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional Strategy</intervention_name>
    <description>Counseling based on dietary goals and mindfulness techniques.</description>
    <arm_group_label>Nutritional Strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Prescription</intervention_name>
    <description>Dietary prescription according to guidelines.</description>
    <arm_group_label>Dietary Prescription</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: ≥21 years old with medical diagnosis of hypertension, systolic blood&#xD;
        pressure (SBP) ≥140 mmHg at the moment of the screening and who have not received or&#xD;
        received nutritional counseling for at least 06 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of resistant and/or secondary hypertension;&#xD;
&#xD;
          -  Severe neuropathy;&#xD;
&#xD;
          -  Chronic kidney disease;&#xD;
&#xD;
          -  Active cancer or life expectancy &lt;6 months;&#xD;
&#xD;
          -  Chemical dependence or use of antipsychotic drugs;&#xD;
&#xD;
          -  Autoimmune disease or chronic use of steroids;&#xD;
&#xD;
          -  Pregnancy and lactation;&#xD;
&#xD;
          -  Acute coronary syndrome in the last 60 days;&#xD;
&#xD;
          -  Severe or unstable heart failure;&#xD;
&#xD;
          -  Wheelchair users;&#xD;
&#xD;
          -  Extreme obesity (body mass index [BMI] ≥40kg / m²);&#xD;
&#xD;
          -  Cognitive, neurological or psychiatric condition that prevents participation in the&#xD;
             study;&#xD;
&#xD;
          -  Participation in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aline Marcadenti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital do Coracao</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de Fortaleza</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Goiás - Universidade Federal de Goiás</name>
      <address>
        <city>Goiânia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Tocantins</name>
      <address>
        <city>Palmas</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Cardiologia do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontifícia Universidade Católica do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade de São Paulo</name>
      <address>
        <city>Ribeirão Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Coracao</name>
      <address>
        <city>São Paulo</city>
        <zip>04004-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Comunitário São Peregrino Lazziozi</name>
      <address>
        <city>Veranópolis</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 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>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.</ipd_description>
    <ipd_time_frame>Data will be available after main paper publication.</ipd_time_frame>
  </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/NCT03793881
org study id: NUPRESS
nct id: NCT03793881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adherence to a healthy dietary pattern is part of the self-care of patients with
      hypertension, and may contribute substantially to therapeutic target goals as well as to a
      better quality of life. However, not all nutritional recommendations aimed at these patients
      are easily applicable in clinical practice. The primary objective of the study is to evaluate
      the effectiveness of a nutritional strategy for blood pressure control in patients with
      hypertension users of a Public Health System after 6 months of follow-up. As secondary
      objectives, we will evaluate the impact of the proposed strategy on self-care and on the
      quality of life of the patients. In this multicenter open-label randomized trial, 408
      patients ≥21 years old with hypertension, systolic blood pressure (SBP) ≥140mmHg at the
      moment of the screening and who have not received or received nutritional counseling for at
      least 06 months will be enrolled. Patients allocated to the control group will receive
      individualized dietary prescription according to the guidelines of the Brazilian Society of
      Cardiology. Nutritional counseling in the intervention group will be performed based on the
      quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness
      and mindful eating; all dietary guidance will be based on feasible goals built together
      (patient and nutritionist), and no diet will be prescribed for intervention group. In both
      groups, patients will receive automatic monitors for residential self-monitoring blood
      pressure. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final
      consultation). At 120 and 150 days, participants in the intervention group will receive
      motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be
      a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum
      sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed
      at baseline and 180 days; anthropometric indexes and diastolic blood pressure (DBP) will be
      also evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SBP
time frame: 6 months
description: Systolic blood pressure, in mmHg
measure: BPC
time frame: 6 months
description: Blood pressure control, defined as either having systolic blood pressure (SBP) > 140 mmHg at baseline and achieving SBP ≤ 140 mmHg after follow-up or having SBP ≤ 140 mmHg at baseline and reducing anti-hypertensive drugs after follow-up.
measure: DBP
time frame: 6 months
description: Diastolic blood pressure, in mmHg
measure: HbA1C
time frame: 6 months
description: Glycated hemoglobin, in %
measure: FG
time frame: 6 months
description: Fasting glucose, in mg/dL
measure: BW
time frame: 6 months
description: Body weight, in kg
measure: WC
time frame: 6 months
description: Waist circumference, in cm
measure: BMI
time frame: 6 months
description: Body mass index, in kg/m2; it will be defined according to the mathematical formula (BW/height*height)
measure: TC
time frame: 6 months
description: Total cholesterol, in mg/dL
measure: LDL-c
time frame: 6 months
description: LDL cholesterol, in mg/dL; it will be defined according to the Martin´s mathematical formula
measure: HDL-c
time frame: 6 months
description: HDL cholesterol, in mg/dL
measure: TG
time frame: 6 months
description: Serum triglycerides, in mg/dL
measure: VLDL-c
time frame: 6 months
description: VLDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TG/5
measure: NHDL
time frame: 6 months
description: Non-HDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TC-HDL-c
measure: Castelli Index I
time frame: 6 months
description: Castelli Index I, in mg/dL; it will be obtained according to the mathematical formula TC/HDL-c
measure: Castelli Index II
time frame: 6 months
description: Castelli Index II, in mg/dL; it will be obtained according to the mathematical formula LDL-c/HDL-c
measure: Cr
time frame: 6 months
description: Creatinine, in mg/dL
measure: GFR
time frame: 6 months
description: Glomerular filtration rate, in ml/min/1.73m2
measure: Sodium (s)
time frame: 6 months
description: Serum sodium, in mEq/L
measure: Sodium (u)
time frame: 6 months
description: Urinary sodium, in mEq/L
measure: Potassium (s)
time frame: 6 months
description: Serum potassium, in mEq/L
measure: Potassium (u)
time frame: 6 months
description: Urinary potassium, in mEq/L
measure: ALB
time frame: 6 months
description: Albuminuria, in mg/g
measure: DQ
time frame: 6 months
description: Diet quality, assessed by the modified Alternative Healthy Eating Index (mAHEI)
measure: MINICHAL
time frame: 6 months
description: Quality of life evaluated by the Brazilian version of the Mini-cuestionario de calidad de vida en la hipertensión arterial. In this tool, ten items are related to the "mental status" domain and six items to "somatic manifestations". Questions refer to the past seven days. The score scale is a likert-type scale with four possible answers (0=absolutely no; 1=yes, a little; 2=yes, fairly; 3=yes, a lot). The points range from 0 (best health level) to 30 (worst health level) for the "mental status" dimension, and from 0 (best health level) to 18 (worst health level) for the "somatic manifestations" dimension.
measure: SHIQ
time frame: 6 months
description: Self-care evaluated by the Brazilian version of the Self-care of Hypertension Inventory Questionaire. This tool includes 23 items divided across 3 scales: Self-care Maintenance (11 items), Self-care Management (6 items), and Self-care Confidence (6 items). Items in the instrument are scored on a Likert-type scale. In the Self-care Maintenance domain, scores range from 1 to 5 (''never'' to ''always''). In the Self-care Management domain, 2 items range from 0 to 5 to capture a fully negative response, and other item options are scored 1 to 5. The remaining items are scored from 1 to 5 (''not likely'' to ''very likely''). In the self-care confidence scale, items are scored from 1 to 5. Scores are calculated for each scale individually. Each scale is standardized to range from 0 to 100. Self-care is considered adequate if the score is 70 or greater.
measure: TT
time frame: 6 months
description: Therapeutic targets, defined as the proportion of participants who reached the following therapeutic targets: SBP/DBP < 140/90 mmHg; fasting glucose <100 mg/dL; LDL-c <100 mg/dL; BMI < 25 kg/m2 or weight loss > 5%
measure: AHD
time frame: 6 months
description: Anti-hypertensive drugs, defined as the type and proportion of anti-hypertensive drugs used
arm group label: Nutritional Strategy
arm group type: Experimental
description: Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist).
arm group label: Dietary Prescription
arm group type: Active Comparator
description: Individualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology.
intervention type: Behavioral
intervention name: Nutritional Strategy
description: Counseling based on dietary goals and mindfulness techniques.
arm group label: Nutritional Strategy
intervention type: Behavioral
intervention name: Dietary Prescription
description: Dietary prescription according to guidelines.
arm group label: Dietary Prescription
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Aline Marcadenti, PhD
role: Principal Investigator
affiliation: Hospital do Coracao
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes
ipd description: Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.
ipd time frame: Data will be available after main paper publication.