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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

NCTNCT03831880 (opens ClinicalTrials.gov in a new tab)Other idC0311002Other id2018-000918-38Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
87 participants (actual)
Sponsor
Pfizer · Industry
Design
Randomized · Open label (no masking)
Countries
5 countries

United States, Bulgaria, Czechia, Slovakia, United Kingdom

Start
7 Feb 2019
Primary completion
28 Aug 2020
Completion
28 Aug 2020
First posted
6 Feb 2019
Last update posted
14 Oct 2021
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 3

    Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

    NCT03831880

    7 Feb 2019 to 28 Aug 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who have been stable on treatment with daily Genotropin will be enrolled.

Interventions

  • GenotropinDrug
  • somatrogonDrug

Arms2

  • Other

    Daily to Weekly

    Genotropin to somatrogon

  • Other

    Weekly to Daily

    somatrogon to Genotropin

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire

    Time frame · Baseline

    Registry description

    Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).

  2. Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire

    Time frame · Week 12

    Registry description

    Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).

  3. Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire

    Time frame · Week 24

    Registry description

    Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).

  4. Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).

Secondary outcomes(20)

  1. Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  2. Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the IPAQ PRO tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  3. Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to ease of the injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  4. Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to ease of the injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  5. Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 7-point scale: 1=extremely convenient to 7=extremely inconvenient. The total score related to convenience of injection schedule ranged from 1 to 7; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  6. Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 7-point scale: 1=extremely convenient to 7=extremely inconvenient. The total score related to convenience of injection schedule ranged from 1 to 7; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  7. Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant satisfaction with treatment and used a 5-point scale: 1=very satisfied to 5=very dissatisfied. The total score related to satisfaction with overall treatment ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  8. Total Score Related to Satisfaction With Overall Treatment Experience by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant satisfaction with treatment and used a 5-point scale: 1=very satisfied to 5=very dissatisfied. The total score related to satisfaction with overall treatment ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  9. Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant willingness to continue treatment and used a 5-point scale: 1=extremely willing to 5=not at all willing. The total score related to willingness to continue injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  10. Total Scores Related to Willingness to Continue Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to participant willingness to continue treatment and used a 5-point scale: 1=extremely willing to 5=not at all willing. The total score related to willingness to continue injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome.

  11. Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participants (8-17 years old). Participants were asked 4 questions from Section I of the IPAQ PRO tool related to participant's injection signs and symptoms and used a 11-point scale: 0=no pain to 10=worst possible pain; 0=no stinging to 10=worst possible stinging; 0=no bruising to 10=worst possible bruising; and 0=no bleeding to 10=worst possible bleeding, respectively. The total score was sum of all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for injection signs and symptoms meant a better outcome.

  12. Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participants (8-17 years old). Participants were asked 4 questions from Section I of the IPAQ PRO tool related to participant's injection signs and symptoms and used a 11-point scale: 0=no pain to 10=worst possible pain; 0=no stinging to 10=worst possible stinging; 0=no bruising to 10=worst possible bruising; and 0=no bleeding to 10=worst possible bleeding, respectively. The total score was sum of all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for injection signs and symptoms meant a better outcome.

  13. Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged <8 Years Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by caregiver for children under 8 years. Participants were asked 2 questions from Section I of the IPAQ PRO tool related to participant's assessment of signs and used a 11-point scale: 0=no bruising to 10=worst possible bruising and 0=no bleeding to 10=worst possible bleeding, respectively. The total score was sum of all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for assessment of signs meant a better outcome.

  14. Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged <8 Years by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by caregiver for children under 8 years. Participants were asked 2 questions from Section I of the IPAQ PRO tool related to participant's assessment of signs and used a 11-point scale: 0=no bruising to 10=worst possible bruising and 0=no bleeding to 10=worst possible bleeding, respectively. The total score was sum of all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for assessment of signs meant a better outcome.

  15. Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by caregiver. Participants were asked 13 questions from Section I of the IPAQ PRO tool related to caregiver life interference and used a 5-point scale: 1= never to 5= always. The total score ranged was sum of scores from all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for caregiver and family life interference meant less life interference (a better outcome).

  16. Total Scores Related to Caregiver Life Interference, Including Family Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by caregiver. Participants were asked 13 questions from Section I of the IPAQ PRO tool related to caregiver life interference and used a 5-point scale: 1= never to 5= always. The total score ranged was sum of scores from all questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for caregiver and family life interference meant less life interference (a better outcome).

  17. Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

    Time frame · Baseline, Week 12, Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to number of missed injections (daily or weekly administration) during past 4 weeks. The total scores ranged from 0 to 31 for daily administration (Genotropin) and from 0 to 5 for weekly administration (Somatrogon). All scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for missed injections meant a better outcome.

  18. Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire

    Time frame · Baseline up to Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to number of missed injections (daily or weekly administration) during past 4 weeks. The total scores ranged from 0 to 31 for daily administration (Genotropin) and from 0 to 5 for weekly administration (Somatrogon). All scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score for missed injections meant a better outcome.

  19. Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire

    Time frame · Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregivers responded to question from Section II of the IPAQ PRO tool "If you were given the choice between the daily growth hormone injection pen and the weekly growth hormone injection pen, which pen would you choose?" Response was: 1) the daily injection pen (Genotropin) or 2) the weekly injection pen (Somatrogon).

  20. Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire

    Time frame · Week 24

    Registry description

    Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregivers responded to question from Section II of the IPAQ PRO tool "Which growth hormone injection schedule do you prefer overall?" by choosing from any 1 option from: 1) prefer the weekly injection schedule (Somatrogon); 2) prefer the daily injection schedule (Genotropin); 3) no preference.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline

Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire

GroupValue (units on a scale)Spread
Daily Genotropin Then Weekly Somatrogon29.518.0
Weekly Somatrogon Then Daily Genotropin27.119.8
Primary outcomeMean· Week 12

Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire

GroupValue (units on a scale)Spread
Daily Genotropin Then Weekly Somatrogon25.217.3
Weekly Somatrogon Then Daily Genotropin7.17.8
Primary outcomeMean· Week 24

Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire

GroupValue (units on a scale)Spread
Daily Genotropin Then Weekly Somatrogon9.513.3
Weekly Somatrogon Then Daily Genotropin23.022.6
Primary outcomeMean· Baseline up to Week 24

Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire

GroupValue (units on a scale)
Genotropin24.13
Somatrogon8.63
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline, Week 12, Week 24

Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

GroupValue (units on a scale)Spread
Daily Genotropin Then Weekly Somatrogon10.611.3
Weekly Somatrogon Then Daily Genotropin11.612.8
Secondary outcomeMean· Baseline up to Week 24

Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire

GroupValue (units on a scale)
Genotropin10.71
Somatrogon5.32
Secondary outcomeMean· Baseline, Week 12, Week 24

Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire

GroupValue (units on a scale)Spread
Daily Genotropin Then Weekly Somatrogon18.520.0
Weekly Somatrogon Then Daily Genotropin16.317.5
Secondary outcomeMean· Baseline up to Week 24

Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire

GroupValue (units on a scale)
Genotropin20.56
Somatrogon6.96

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GenotropinParticipants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).0 / 860 / 8638 / 86
SomatrogonParticipants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).0 / 870 / 8747 / 87

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Children aged 3 years old and \<18 years with either isolated GHD, or GH insufficiency. 2. Currently on treatment with either Genotropin Pen®, Genotropin GoQuick Pen®, HumatroPen® (United States of America \[USA\] only), or Omnitrope® Pen (USA only) ≥3 months and have been compliant on a stable dose (±10%) for at least 3 months prior to screening. 3. IGF I SDS \< 2. 4. Subjects on hormonal replacement therapy for other hypothalamic pituitary axis (HPA) hormonal deficiencies and/or diabetes insipidus must be on an optimized and stable treatment regimen, as determined by the Investigator, for at least 3 months prior to screening. Exclusion Criteria 1. History of leukemia, lymphoma, sarcoma or any other cancer. 2. History of radiation therapy or chemotherapy. 3. Children with psychosocial dwarfism. 4. Children born small for gestational age (SGA) - birth weight and/or birth length \< 2 SDS for gestational age. 5. Other causes of short stature such as uncontrolled primary hypothyroidism and rickets. 6. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader Willi syndrome, Russell Silver syndrome, short stature homeobox (SHOX) mutations/deletions or skeletal dysplasias. 7. Treatment with regularly scheduled daily or weekly injectable medications other than Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA only). 8. Diabetes Mellitus. 9. Current treatment with Genotropin MiniQuick. 10. History of any exposure to a long acting hGH preparation. 11. Known or suspected human immunodeficiency virus (HIV) positive patient, or patient with advanced diseases such as acquired immunodeficiency syndrome (AIDS) or tuberculosis. 12. Drug, substance, or alcohol abuse. 13. Known hypersensitivity to the components of the medication. 14. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product. 15. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 16. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study. 17. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation. 18. Patient and/or the parent/legal guardian are likely to be non-compliant with respect to study conduct. 19. Subject and/or the parent/legal guardian are unable to understand written and/or verbal instructions on the proper use of growth hormone injection devices. 20. Children with closed epiphyses (this determination can be based on available existing clinical data).

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