<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/NCT03831880</url>
  </required_header>
  <id_info>
    <org_study_id>C0311002</org_study_id>
    <secondary_id>2018-000918-38</secondary_id>
    <nct_id>NCT03831880</nct_id>
  </id_info>
  <brief_title>Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD</brief_title>
  <official_title>A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label randomized 24 week crossover trial assessing the treatment burden of a&#xD;
      weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone&#xD;
      injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who&#xD;
      have been stable on treatment with daily Genotropin will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment&#xD;
      with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks&#xD;
      of treatment with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin.&#xD;
      Subjects will have study visits at Baseline, Weeks 6, 12, 18, and 24. Subjects will also be&#xD;
      followed up by phone 8 to 12 days after each treatment period begins (Week 1 and Week 13).&#xD;
      Subjects and caregivers (as a Dyad) will complete questionnaires assessing treatment burden&#xD;
      at baseline and at the end of each 12 week treatment period. All subjects/caregivers will&#xD;
      receive a follow up phone call at Week 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">August 28, 2020</completion_date>
  <primary_completion_date type="Actual">August 28, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire</measure>
    <time_frame>Week 12</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score Related to Satisfaction With Overall Treatment Experience by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Willingness to Continue Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged &lt;8 Years Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged &lt;8 Years by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Caregiver Life Interference, Including Family Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <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 &quot;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?&quot; Response was: 1) the daily injection pen (Genotropin) or 2) the weekly injection pen (Somatrogon).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <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 &quot;Which growth hormone injection schedule do you prefer overall?&quot; by choosing from any 1 option from: 1) prefer the weekly injection schedule (Somatrogon); 2) prefer the daily injection schedule (Genotropin); 3) no preference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <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 &quot;Which growth hormone injection schedule was more convenient overall?&quot; by choosing from any 1 option from: 1) weekly injection schedule was more convenient (Somatrogon); 2) daily injection schedule was more convenient (Genotropin); 3) no difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <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 &quot;Which growth hormone injection schedule was easier to follow overall?&quot; by choosing from any 1 option from: 1) easier to follow weekly injection schedule (Somatrogon); 2) easier to follow daily injection schedule (Genotropin); 3) no difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;Which pen was easier to use?&quot; from Section II of the IPAQ PRO tool. Question had 4 parts: preparing the injection pen (Part I), setting the dose (Part II), injecting the medicine (Part III) and storing the pen (Part IV). Participants/caregiver expressed their preference by choosing from any 1 option for each activity from: 1) weekly pen easier to use (Somatrogon); 2) daily pen easier to use (Genotropin); 3) no difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to participant life interference. Participants were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). The participants expressed their preference by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <description>Caregivers of participants were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to caregiver life interference and were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference. The caregivers responded for the participants, and in actual they respond to the number of participants only but per caregiver responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/ caregiver were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to family life interference and assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;How beneficial was to take injections less often?&quot; from Section II of the IPAQ PRO tool pertaining to benefit relating to the Injection schedule and used a 5-point scale: 1= extremely beneficial, 2= very beneficial, 3= moderately beneficial, 4= slightly beneficial and 5= not at all beneficial. Lower score of benefit relating to injection schedule meant a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire</measure>
    <time_frame>Week 24</time_frame>
    <description>Participants/caregiver dyads were asked 4 questions &quot;Which schedule would be better able to follow?&quot; (Question 1), &quot;Which schedule would be more likely to follow for a longer time?&quot; (Question 2), &quot;Which schedule would be better able to follow for a longer time?&quot; (Question 3) and &quot;Which schedule would be more likely to follow?&quot; (Question 4) from Section II of the IPAQ PRO tool related to participant intention to comply with treatment. Options for each question were: 1) weekly injection (Somatrogon) 2) daily injection (Genotropin), or 3) no difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score by Treatment in Overall Study</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs</measure>
    <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 Weeks)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were defined as events that occurred between first dose of study drug up to 35 days after last dose of study drug. Related TEAEs were those AEs who had relation to the study treatment and was judged by investigator.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Adverse Events According to Severity</measure>
    <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 Weeks)</time_frame>
    <description>AEs were assessed and categorized according to the severity as mild (did not interfered with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Discontinuation Due to Adverse Events (AEs)</measure>
    <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 Weeks)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The discontinuations due to adverse events was defined for participants and reported in this outcome measure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Week 1 to Week 12, Week 13 to Week 24</time_frame>
    <description>The laboratory abnormality parameters included Hematology: erythrocyte (Er.) mean corpuscular volume, Er. mean corpuscular hemoglobin:&lt;0.9*lower limit normal (LLN), leukocytes:&lt;0.6*LLN, lymphocytes:&lt;0.8*LLN, neutrophils:&lt;0.8*LLN, greater than (&gt;) 1.2*upper limit normal (ULN), eosinophils, monocytes:&gt;1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin, indirect bilirubin:&gt;1.5*ULN, gamma glutamyl transferase:&gt;3.0*ULN, albumin:&gt;1.2*ULN, blood urea nitrogen:&gt;1.3*ULN, urate:&gt;1.2*ULN, high-density lipoprotein (HDL) cholesterol:&lt;0.8*LLN, potassium, magnesium:&gt;1.1*ULN, phosphate:&gt;1.2*ULN, bicarbonate:&lt;0.9*LLN, creatine kinase:&gt;2.0*ULN. Urinalysis: specific gravity:&gt;1.030, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase:&gt;=1.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb)</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>Blood samples were collected for determination of rhGH and NAb. The participants who tested positive for antibodies were reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb)</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>Blood samples were collected for determination of anti-somatrogon antibodies and NAb. The participants who tested positive for antibodies were reported.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>Daily to Weekly</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Genotropin to somatrogon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekly to Daily</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>somatrogon to Genotropin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genotropin</intervention_name>
    <description>Genotropin (dose [mg] at time of enrollment) given subcutaneously once daily</description>
    <arm_group_label>Daily to Weekly</arm_group_label>
    <arm_group_label>Weekly to Daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatrogon</intervention_name>
    <description>0.66 mg/kg/week given subcutaneously once weekly</description>
    <arm_group_label>Daily to Weekly</arm_group_label>
    <arm_group_label>Weekly to Daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged 3 years old and &lt;18 years with either isolated GHD, or GH insufficiency.&#xD;
&#xD;
          2. Currently on treatment with either Genotropin Pen®, Genotropin GoQuick Pen®,&#xD;
             HumatroPen® (United States of America [USA] only), or Omnitrope® Pen (USA only) ≥3&#xD;
             months and have been compliant on a stable dose (±10%) for at least 3 months prior to&#xD;
             screening.&#xD;
&#xD;
          3. IGF I SDS &lt; 2.&#xD;
&#xD;
          4. Subjects on hormonal replacement therapy for other hypothalamic pituitary axis (HPA)&#xD;
             hormonal deficiencies and/or diabetes insipidus must be on an optimized and stable&#xD;
             treatment regimen, as determined by the Investigator, for at least 3 months prior to&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of leukemia, lymphoma, sarcoma or any other cancer.&#xD;
&#xD;
          2. History of radiation therapy or chemotherapy.&#xD;
&#xD;
          3. Children with psychosocial dwarfism.&#xD;
&#xD;
          4. Children born small for gestational age (SGA) - birth weight and/or birth length &lt; 2&#xD;
             SDS for gestational age.&#xD;
&#xD;
          5. Other causes of short stature such as uncontrolled primary hypothyroidism and rickets.&#xD;
&#xD;
          6. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan&#xD;
             syndrome, Prader Willi syndrome, Russell Silver syndrome, short stature homeobox&#xD;
             (SHOX) mutations/deletions or skeletal dysplasias.&#xD;
&#xD;
          7. Treatment with regularly scheduled daily or weekly injectable medications other than&#xD;
             Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA&#xD;
             only).&#xD;
&#xD;
          8. Diabetes Mellitus.&#xD;
&#xD;
          9. Current treatment with Genotropin MiniQuick.&#xD;
&#xD;
         10. History of any exposure to a long acting hGH preparation.&#xD;
&#xD;
         11. Known or suspected human immunodeficiency virus (HIV) positive patient, or patient&#xD;
             with advanced diseases such as acquired immunodeficiency syndrome (AIDS) or&#xD;
             tuberculosis.&#xD;
&#xD;
         12. Drug, substance, or alcohol abuse.&#xD;
&#xD;
         13. Known hypersensitivity to the components of the medication.&#xD;
&#xD;
         14. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and&#xD;
             female subjects of childbearing potential who are unwilling or unable to use a highly&#xD;
             effective method of contraception as outlined in this protocol for the duration of the&#xD;
             study and for at least 28 days after the last dose of investigational product.&#xD;
&#xD;
         15. Other acute or chronic medical or psychiatric condition including recent (within the&#xD;
             past year) or active suicidal ideation or behavior or laboratory abnormality that may&#xD;
             increase the risk associated with study participation or investigational product&#xD;
             administration or may interfere with the interpretation of study results and, in the&#xD;
             judgment of the investigator, would make the subject inappropriate for entry into this&#xD;
             study.&#xD;
&#xD;
         16. Investigator site staff members directly involved in the conduct of the study and&#xD;
             their family members, site staff members otherwise supervised by the investigator, or&#xD;
             subjects who are Pfizer employees, including their family members, directly involved&#xD;
             in the conduct of the study.&#xD;
&#xD;
         17. Participation in other studies involving investigational drug(s) within 30 days prior&#xD;
             to study entry and/or during study participation.&#xD;
&#xD;
         18. Patient and/or the parent/legal guardian are likely to be non-compliant with respect&#xD;
             to study conduct.&#xD;
&#xD;
         19. Subject and/or the parent/legal guardian are unable to understand written and/or&#xD;
             verbal instructions on the proper use of growth hormone injection devices.&#xD;
&#xD;
         20. Children with closed epiphyses (this determination can be based on available existing&#xD;
             clinical data).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center of Excellence in Diabetes and Endocrinology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Pediatric Endocrinology</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Endocrine Associates, PC</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Health System</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Specialty Care</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Biomedical Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Clinic</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shriners Hospitals for Children</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Children's Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Pharmacy</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Health System - Mary Bridge Children's Health Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research &amp; Innovation</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Pediatric Clinic UMHAT &quot;St. Marina&quot; EAD</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Brno, Pediatricka Klinika</name>
      <address>
        <city>Brno</city>
        <zip>61300</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnicni lekarna FN Brno</name>
      <address>
        <city>Brno</city>
        <zip>61300</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice v Motole, Pediatricka klinika 2.LF UK a FN Motol</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnicni lekarna FN Motol</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnicna Lekaren Nudch</name>
      <address>
        <city>Bratislava</city>
        <zip>833 40</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Národný ústav detských chorôb, Detská klinika</name>
      <address>
        <city>Bratislava</city>
        <zip>833 40</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detská fakultná nemocnica Košice Klinika detí a dorastu LF UPJŠ a DFN</name>
      <address>
        <city>Kosice</city>
        <zip>040 11</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnica lekaren DFN Kosice, Klinika deti a dorastu</name>
      <address>
        <city>Kosice</city>
        <zip>040 11</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Georges University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Georges University Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Institute of Child Health, University College London</name>
      <address>
        <city>London</city>
        <zip>WC1N 1EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIHR Clinical Research Facility, Great Ormond Street Hospital for Children NHS Trust</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Slovakia</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C0311002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <results_first_submitted>August 20, 2021</results_first_submitted>
  <results_first_submitted_qc>October 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2021</results_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</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>Dwarfism, Pituitary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03831880/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03831880/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>107 participants were screened for study eligibility. 87 Participants, aged 3 to less than 18 years with growth hormone deficiency (GHD) on stable treatment with somatropin, were deemed eligible for enrollment and randomized to receive treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Daily Genotropin Then Weekly Somatrogon</title>
          <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
        </group>
        <group group_id="P2">
          <title>Weekly Somatrogon Then Daily Genotropin</title>
          <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (12 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse event, not serious</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 (12 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up (5 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="43">1 participant who discontinued from Period 1 completed follow-up visit.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Daily Genotropin Then Weekly Somatrogon</title>
          <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
        </group>
        <group group_id="B2">
          <title>Weekly Somatrogon Then Daily Genotropin</title>
          <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.8" spread="3.4"/>
                    <measurement group_id="B2" value="10.7" spread="3.7"/>
                    <measurement group_id="B3" value="10.7" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire</title>
        <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).</description>
        <time_frame>Baseline</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire</title>
          <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).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" spread="18.0"/>
                    <measurement group_id="O2" value="27.1" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire</title>
        <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).</description>
        <time_frame>Week 12</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire</title>
          <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).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" spread="17.3"/>
                    <measurement group_id="O2" value="7.1" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire</title>
        <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).</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire</title>
          <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).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="13.3"/>
                    <measurement group_id="O2" value="23.0" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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).</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.13" lower_limit="20.61" upper_limit="27.65"/>
                    <measurement group_id="O2" value="8.63" lower_limit="5.05" upper_limit="12.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.71</ci_lower_limit>
            <ci_upper_limit>-11.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="11.3"/>
                    <measurement group_id="O2" value="11.6" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="13.8"/>
                    <measurement group_id="O2" value="5.1" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="9.3"/>
                    <measurement group_id="O2" value="9.4" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.71" lower_limit="8.27" upper_limit="13.14"/>
                    <measurement group_id="O2" value="5.32" lower_limit="2.84" upper_limit="7.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0017</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.69</ci_lower_limit>
            <ci_upper_limit>-2.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" spread="20.0"/>
                    <measurement group_id="O2" value="16.3" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" spread="25.2"/>
                    <measurement group_id="O2" value="4.4" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="18.3"/>
                    <measurement group_id="O2" value="17.9" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.56" lower_limit="16.22" upper_limit="24.89"/>
                    <measurement group_id="O2" value="6.96" lower_limit="2.54" upper_limit="11.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.74</ci_lower_limit>
            <ci_upper_limit>-7.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" spread="21.0"/>
                    <measurement group_id="O2" value="32.5" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3" spread="23.9"/>
                    <measurement group_id="O2" value="7.9" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="14.4"/>
                    <measurement group_id="O2" value="33.3" spread="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.30" lower_limit="30.13" upper_limit="38.47"/>
                    <measurement group_id="O2" value="9.96" lower_limit="5.71" upper_limit="14.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-24.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.10</ci_lower_limit>
            <ci_upper_limit>-18.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Satisfaction With Overall Treatment Experience Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" spread="21.5"/>
                    <measurement group_id="O2" value="29.4" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" spread="27.2"/>
                    <measurement group_id="O2" value="20.0" spread="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" spread="32.3"/>
                    <measurement group_id="O2" value="30.4" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score Related to Satisfaction With Overall Treatment Experience by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score Related to Satisfaction With Overall Treatment Experience by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.95" lower_limit="22.55" upper_limit="35.36"/>
                    <measurement group_id="O2" value="21.13" lower_limit="14.61" upper_limit="27.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0739</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.42</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Willingness to Continue Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" spread="20.0"/>
                    <measurement group_id="O2" value="22.5" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" spread="27.6"/>
                    <measurement group_id="O2" value="10.6" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="24.8"/>
                    <measurement group_id="O2" value="30.4" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Willingness to Continue Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Willingness to Continue Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.54" lower_limit="23.95" upper_limit="35.12"/>
                    <measurement group_id="O2" value="11.93" lower_limit="6.24" upper_limit="17.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-17.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.15</ci_lower_limit>
            <ci_upper_limit>-10.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure. Here 'number analyzed' signifies participants aged 8 years or above and evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>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</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure. Here 'number analyzed' signifies participants aged 8 years or above and evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="10.4"/>
                    <measurement group_id="O2" value="13.8" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" spread="12.2"/>
                    <measurement group_id="O2" value="13.7" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="12.2"/>
                    <measurement group_id="O2" value="10.9" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants aged 8 years or above and evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Injection Signs and Symptoms for Participants Aged 8 Years and Above by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants aged 8 years or above and evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.56" lower_limit="10.78" upper_limit="16.34"/>
                    <measurement group_id="O2" value="14.27" lower_limit="11.32" upper_limit="17.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6137</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.09</ci_lower_limit>
            <ci_upper_limit>3.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged &lt;8 Years Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure. Here 'number analyzed' signifies participants aged 8 years or below and evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged &lt;8 Years Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure. Here 'number analyzed' signifies participants aged 8 years or below and evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2" spread="14.6"/>
                    <measurement group_id="O2" value="13.5" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="10.6"/>
                    <measurement group_id="O2" value="13.0" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="7.8"/>
                    <measurement group_id="O2" value="9.4" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged &lt;8 Years by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants aged 8 years or below and evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Assessment of Signs, Completed by Caregiver for Children Aged &lt;8 Years by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants aged 8 years or below and evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.75" lower_limit="2.65" upper_limit="14.86"/>
                    <measurement group_id="O2" value="9.31" lower_limit="3.47" upper_limit="15.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8404</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.29</ci_lower_limit>
            <ci_upper_limit>6.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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).</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Caregiver Life Interference, Including Family Life Interference Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8" spread="17.5"/>
                    <measurement group_id="O2" value="20.0" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="16.7"/>
                    <measurement group_id="O2" value="3.1" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="6.0"/>
                    <measurement group_id="O2" value="18.1" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Caregiver Life Interference, Including Family Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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).</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Caregiver Life Interference, Including Family Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.01" lower_limit="13.77" upper_limit="20.25"/>
                    <measurement group_id="O2" value="3.54" lower_limit="0.24" upper_limit="6.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.59</ci_lower_limit>
            <ci_upper_limit>-9.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Missed Injections Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="15.1"/>
                    <measurement group_id="O2" value="7.3" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="8.2"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="7.4"/>
                    <measurement group_id="O2" value="3.1" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
        <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.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire</title>
          <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.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" lower_limit="2.03" upper_limit="5.39"/>
                    <measurement group_id="O2" value="0.95" lower_limit="-0.76" upper_limit="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0245</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.16</ci_lower_limit>
            <ci_upper_limit>-0.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <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 &quot;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?&quot; Response was: 1) the daily injection pen (Genotropin) or 2) the weekly injection pen (Somatrogon).</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <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 &quot;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?&quot; Response was: 1) the daily injection pen (Genotropin) or 2) the weekly injection pen (Somatrogon).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <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 &quot;Which growth hormone injection schedule do you prefer overall?&quot; by choosing from any 1 option from: 1) prefer the weekly injection schedule (Somatrogon); 2) prefer the daily injection schedule (Genotropin); 3) no preference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <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 &quot;Which growth hormone injection schedule do you prefer overall?&quot; by choosing from any 1 option from: 1) prefer the weekly injection schedule (Somatrogon); 2) prefer the daily injection schedule (Genotropin); 3) no preference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <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 &quot;Which growth hormone injection schedule was more convenient overall?&quot; by choosing from any 1 option from: 1) weekly injection schedule was more convenient (Somatrogon); 2) daily injection schedule was more convenient (Genotropin); 3) no difference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <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 &quot;Which growth hormone injection schedule was more convenient overall?&quot; by choosing from any 1 option from: 1) weekly injection schedule was more convenient (Somatrogon); 2) daily injection schedule was more convenient (Genotropin); 3) no difference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <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 &quot;Which growth hormone injection schedule was easier to follow overall?&quot; by choosing from any 1 option from: 1) easier to follow weekly injection schedule (Somatrogon); 2) easier to follow daily injection schedule (Genotropin); 3) no difference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <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 &quot;Which growth hormone injection schedule was easier to follow overall?&quot; by choosing from any 1 option from: 1) easier to follow weekly injection schedule (Somatrogon); 2) easier to follow daily injection schedule (Genotropin); 3) no difference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;Which pen was easier to use?&quot; from Section II of the IPAQ PRO tool. Question had 4 parts: preparing the injection pen (Part I), setting the dose (Part II), injecting the medicine (Part III) and storing the pen (Part IV). Participants/caregiver expressed their preference by choosing from any 1 option for each activity from: 1) weekly pen easier to use (Somatrogon); 2) daily pen easier to use (Genotropin); 3) no difference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;Which pen was easier to use?&quot; from Section II of the IPAQ PRO tool. Question had 4 parts: preparing the injection pen (Part I), setting the dose (Part II), injecting the medicine (Part III) and storing the pen (Part IV). Participants/caregiver expressed their preference by choosing from any 1 option for each activity from: 1) weekly pen easier to use (Somatrogon); 2) daily pen easier to use (Genotropin); 3) no difference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part I: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part I: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part I: No difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part II: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part II: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part II: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part III: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part III: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part III: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part IV: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part IV: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part IV: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to participant life interference. Participants were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). The participants expressed their preference by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to participant life interference. Participants were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). The participants expressed their preference by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Activity 1: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 1: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 1: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <description>Caregivers of participants were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to caregiver life interference and were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference. The caregivers responded for the participants, and in actual they respond to the number of participants only but per caregiver responses.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <description>Caregivers of participants were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to caregiver life interference and were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference. The caregivers responded for the participants, and in actual they respond to the number of participants only but per caregiver responses.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Activity 1: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 1: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 1: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/ caregiver were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to family life interference and assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/ caregiver were asked a question &quot;Which injection schedule interfered less?&quot; from Section II of the IPAQ PRO tool related to family life interference and assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Activity 1: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 1: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 1: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;How beneficial was to take injections less often?&quot; from Section II of the IPAQ PRO tool pertaining to benefit relating to the Injection schedule and used a 5-point scale: 1= extremely beneficial, 2= very beneficial, 3= moderately beneficial, 4= slightly beneficial and 5= not at all beneficial. Lower score of benefit relating to injection schedule meant a better outcome.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <description>Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question &quot;How beneficial was to take injections less often?&quot; from Section II of the IPAQ PRO tool pertaining to benefit relating to the Injection schedule and used a 5-point scale: 1= extremely beneficial, 2= very beneficial, 3= moderately beneficial, 4= slightly beneficial and 5= not at all beneficial. Lower score of benefit relating to injection schedule meant a better outcome.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely Beneficial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Beneficial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately Beneficial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly Beneficial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not At All Beneficial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire</title>
        <description>Participants/caregiver dyads were asked 4 questions &quot;Which schedule would be better able to follow?&quot; (Question 1), &quot;Which schedule would be more likely to follow for a longer time?&quot; (Question 2), &quot;Which schedule would be better able to follow for a longer time?&quot; (Question 3) and &quot;Which schedule would be more likely to follow?&quot; (Question 4) from Section II of the IPAQ PRO tool related to participant intention to comply with treatment. Options for each question were: 1) weekly injection (Somatrogon) 2) daily injection (Genotropin), or 3) no difference.</description>
        <time_frame>Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire</title>
          <description>Participants/caregiver dyads were asked 4 questions &quot;Which schedule would be better able to follow?&quot; (Question 1), &quot;Which schedule would be more likely to follow for a longer time?&quot; (Question 2), &quot;Which schedule would be better able to follow for a longer time?&quot; (Question 3) and &quot;Which schedule would be more likely to follow?&quot; (Question 4) from Section II of the IPAQ PRO tool related to participant intention to comply with treatment. Options for each question were: 1) weekly injection (Somatrogon) 2) daily injection (Genotropin), or 3) no difference.</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question 1: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4: Somatrogon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4: Genotropin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4: No Difference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24</title>
        <description>The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24</title>
          <description>The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="14.8"/>
                    <measurement group_id="O2" value="16.3" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" spread="19.4"/>
                    <measurement group_id="O2" value="4.6" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="9.8"/>
                    <measurement group_id="O2" value="22.2" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score by Treatment in Overall Study</title>
        <description>The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score by Treatment in Overall Study</title>
          <description>The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).</description>
          <population>The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.64" lower_limit="17.30" upper_limit="23.99"/>
                    <measurement group_id="O2" value="6.06" lower_limit="2.66" upper_limit="9.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-14.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.72</ci_lower_limit>
            <ci_upper_limit>-10.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were defined as events that occurred between first dose of study drug up to 35 days after last dose of study drug. Related TEAEs were those AEs who had relation to the study treatment and was judged by investigator.</description>
        <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 Weeks)</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were defined as events that occurred between first dose of study drug up to 35 days after last dose of study drug. Related TEAEs were those AEs who had relation to the study treatment and was judged by investigator.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment-Emergent AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Emergent SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Emergent Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Emergent Related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Adverse Events According to Severity</title>
        <description>AEs were assessed and categorized according to the severity as mild (did not interfered with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).</description>
        <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 Weeks)</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events According to Severity</title>
          <description>AEs were assessed and categorized according to the severity as mild (did not interfered with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).</description>
          <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Discontinuation Due to Adverse Events (AEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The discontinuations due to adverse events was defined for participants and reported in this outcome measure.</description>
        <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 Weeks)</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Genotropin</title>
            <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
          </group>
          <group group_id="O2">
            <title>Somatrogon</title>
            <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Discontinuation Due to Adverse Events (AEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The discontinuations due to adverse events was defined for participants and reported in this outcome measure.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>The laboratory abnormality parameters included Hematology: erythrocyte (Er.) mean corpuscular volume, Er. mean corpuscular hemoglobin:&lt;0.9*lower limit normal (LLN), leukocytes:&lt;0.6*LLN, lymphocytes:&lt;0.8*LLN, neutrophils:&lt;0.8*LLN, greater than (&gt;) 1.2*upper limit normal (ULN), eosinophils, monocytes:&gt;1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin, indirect bilirubin:&gt;1.5*ULN, gamma glutamyl transferase:&gt;3.0*ULN, albumin:&gt;1.2*ULN, blood urea nitrogen:&gt;1.3*ULN, urate:&gt;1.2*ULN, high-density lipoprotein (HDL) cholesterol:&lt;0.8*LLN, potassium, magnesium:&gt;1.1*ULN, phosphate:&gt;1.2*ULN, bicarbonate:&lt;0.9*LLN, creatine kinase:&gt;2.0*ULN. Urinalysis: specific gravity:&gt;1.030, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase:&gt;=1.</description>
        <time_frame>Week 1 to Week 12, Week 13 to Week 24</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>The laboratory abnormality parameters included Hematology: erythrocyte (Er.) mean corpuscular volume, Er. mean corpuscular hemoglobin:&lt;0.9*lower limit normal (LLN), leukocytes:&lt;0.6*LLN, lymphocytes:&lt;0.8*LLN, neutrophils:&lt;0.8*LLN, greater than (&gt;) 1.2*upper limit normal (ULN), eosinophils, monocytes:&gt;1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin, indirect bilirubin:&gt;1.5*ULN, gamma glutamyl transferase:&gt;3.0*ULN, albumin:&gt;1.2*ULN, blood urea nitrogen:&gt;1.3*ULN, urate:&gt;1.2*ULN, high-density lipoprotein (HDL) cholesterol:&lt;0.8*LLN, potassium, magnesium:&gt;1.1*ULN, phosphate:&gt;1.2*ULN, bicarbonate:&lt;0.9*LLN, creatine kinase:&gt;2.0*ULN. Urinalysis: specific gravity:&gt;1.030, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase:&gt;=1.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received. Here 'number analyzed' signifies participants evaluable for each specified time points.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 to Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb)</title>
        <description>Blood samples were collected for determination of rhGH and NAb. The participants who tested positive for antibodies were reported.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb)</title>
          <description>Blood samples were collected for determination of rhGH and NAb. The participants who tested positive for antibodies were reported.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Anti-rhGH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Neutralizing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Anti-rhGH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Neutralizing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Anti-rhGH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Neutralizing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb)</title>
        <description>Blood samples were collected for determination of anti-somatrogon antibodies and NAb. The participants who tested positive for antibodies were reported.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received. &quot;0&quot; in number analyzed field denotes that participants who followed the 'Genotropin then Somatrogon' sequence were not tested for anti-somatrogon ADA at Week 12 and participants who followed the 'Somatrogon then Genotropin' sequence were not tested for anti-somatrogon ADA at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Daily Genotropin Then Weekly Somatrogon</title>
            <description>Participants were randomized to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants received Somatrogon, weekly subcutaneously at a dose of 0.66 milligram per kilogram per week (mg/kg/week) for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days (5 weeks) after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Weekly Somatrogon Then Daily Genotropin</title>
            <description>Participants were randomized to receive Somatrogon, weekly subcutaneously at a dose of 0.66 mg/kg/week, for 12 weeks in Period 1. Period 1 was followed by Period 2, where participants continued to receive Genotropin, daily subcutaneously at the same dose which they were receiving at the time of enrollment, for 12 weeks. There was no treatment wash-out period since these participants had to take growth hormone continually. Participants were followed up maximum for 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb)</title>
          <description>Blood samples were collected for determination of anti-somatrogon antibodies and NAb. The participants who tested positive for antibodies were reported.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received. &quot;0&quot; in number analyzed field denotes that participants who followed the 'Genotropin then Somatrogon' sequence were not tested for anti-somatrogon ADA at Week 12 and participants who followed the 'Somatrogon then Genotropin' sequence were not tested for anti-somatrogon ADA at Week 24.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Anti-Somatrogon Antibodies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Neutralizing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Anti-Somatrogon Antibodies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Neutralizing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Anti-Somatrogon Antibodies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Neutralizing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 35 days after last dose of study drug (up to 29 weeks)</time_frame>
      <desc>Adverse events reported here are per treatment participants received during the study (either in Period 1 or Period 2). Safety set was evaluated.</desc>
      <group_list>
        <group group_id="E1">
          <title>Genotropin</title>
          <description>Participants received Genotropin, daily subcutaneously, in overall study (either in Period 1 or in Period 2).</description>
        </group>
        <group group_id="E2">
          <title>Somatrogon</title>
          <description>Participants received Somatrogon, weekly subcutaneously, at a dose of 0.66 mg/kg/week, in overall study (either in Period 1 or in Period 2).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hyperacusis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenocortical insufficiency acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration site oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Administration site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Fat tissue increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Conjunctivitis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Insulin-like growth factor increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Emotional distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Excessive exercise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03831880
org study id: C0311002
secondary id: 2018-000918-38
nct id: NCT03831880
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment
      with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks
      of treatment with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin.
      Subjects will have study visits at Baseline, Weeks 6, 12, 18, and 24. Subjects will also be
      followed up by phone 8 to 12 days after each treatment period begins (Week 1 and Week 13).
      Subjects and caregivers (as a Dyad) will complete questionnaires assessing treatment burden
      at baseline and at the end of each 12 week treatment period. All subjects/caregivers will
      receive a follow up phone call at Week 28.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire
time frame: Baseline
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).
measure: Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire
time frame: Week 12
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).
measure: Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire
time frame: Week 24
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).
measure: Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire
time frame: Baseline up to Week 24
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).
measure: 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
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.
measure: Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire
time frame: Baseline up to Week 24
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: 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
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).
measure: 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
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).
measure: 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
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.
measure: Total Scores Related to Missed Injections by Treatment in Overall Study, Using DCOA 1 Questionnaire
time frame: Baseline up to Week 24
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.
measure: Number of Participants as Per Responses to Choice of Injection Pen Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
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).
measure: Number of Participants as Per Responses to Preferred Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
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.
measure: Number of Participants as Per Responses to Convenience of the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
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 was more convenient overall?" by choosing from any 1 option from: 1) weekly injection schedule was more convenient (Somatrogon); 2) daily injection schedule was more convenient (Genotropin); 3) no difference.
measure: Number of Participants as Per Responses to Ease of Following Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
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 was easier to follow overall?" by choosing from any 1 option from: 1) easier to follow weekly injection schedule (Somatrogon); 2) easier to follow daily injection schedule (Genotropin); 3) no difference.
measure: Number of Participants as Per Responses to Pen Ease of Use Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
description: Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question "Which pen was easier to use?" from Section II of the IPAQ PRO tool. Question had 4 parts: preparing the injection pen (Part I), setting the dose (Part II), injecting the medicine (Part III) and storing the pen (Part IV). Participants/caregiver expressed their preference by choosing from any 1 option for each activity from: 1) weekly pen easier to use (Somatrogon); 2) daily pen easier to use (Genotropin); 3) no difference.
measure: Number of Participants as Per Responses to Participant Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
description: Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question "Which injection schedule interfered less?" from Section II of the IPAQ PRO tool related to participant life interference. Participants were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). The participants expressed their preference by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.
measure: Number of Participants as Per Responses to Caregiver Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
description: Caregivers of participants were asked a question "Which injection schedule interfered less?" from Section II of the IPAQ PRO tool related to caregiver life interference and were assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference. The caregivers responded for the participants, and in actual they respond to the number of participants only but per caregiver responses.
measure: Number of Participants as Per Responses to Family Life Interference Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
description: Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/ caregiver were asked a question "Which injection schedule interfered less?" from Section II of the IPAQ PRO tool related to family life interference and assessed for 5 activities: daily activities (Activity 1), social activities (Activity 2), recreation/leisure activities (Activity 3), spending night away from home (Activity 4) and travel (Activity 5). Preference was expressed by choosing from any 1 option for each activity from: 1) weekly injection schedule interfered less (Somatrogon); 2) daily injection schedule interfered less (Genotropin); 3) no difference.
measure: Number of Participants as Per Response to Benefit Relating to the Injection Schedule Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
description: Participants were assessed for their treatment experience using DCOA 2 questionnaire completed by participant/caregiver dyads. Participants/caregiver were asked a question "How beneficial was to take injections less often?" from Section II of the IPAQ PRO tool pertaining to benefit relating to the Injection schedule and used a 5-point scale: 1= extremely beneficial, 2= very beneficial, 3= moderately beneficial, 4= slightly beneficial and 5= not at all beneficial. Lower score of benefit relating to injection schedule meant a better outcome.
measure: Number of Participants as Per Responses to Intention to Comply Assessed at Week 24, Using DCOA 2 Questionnaire
time frame: Week 24
description: Participants/caregiver dyads were asked 4 questions "Which schedule would be better able to follow?" (Question 1), "Which schedule would be more likely to follow for a longer time?" (Question 2), "Which schedule would be better able to follow for a longer time?" (Question 3) and "Which schedule would be more likely to follow?" (Question 4) from Section II of the IPAQ PRO tool related to participant intention to comply with treatment. Options for each question were: 1) weekly injection (Somatrogon) 2) daily injection (Genotropin), or 3) no difference.
measure: Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score Assessed at Baseline, Week 12 and Week 24
time frame: Baseline, Week 12, Week 24
description: The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).
measure: Patient Global Impression Severity-Impact on Daily Activities (PGIS-IDA) Score by Treatment in Overall Study
time frame: Baseline up to Week 24
description: The PGIS-IDA rated the severity of the impact on daily activities due to the treatment administration during the past 4 weeks on a 7-point scale (1= not present to 7= extremely severe). Scores were transformed from raw scores to a 0 to 100 scale. Lower scores meant less impact on daily activities (better outcome).
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Treatment Related AEs and SAEs
time frame: Baseline up to 35 days after last dose of study drug (up to 29 Weeks)
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were defined as events that occurred between first dose of study drug up to 35 days after last dose of study drug. Related TEAEs were those AEs who had relation to the study treatment and was judged by investigator.
measure: Number of Participants With Adverse Events According to Severity
time frame: Baseline up to 35 days after last dose of study drug (up to 29 Weeks)
description: AEs were assessed and categorized according to the severity as mild (did not interfered with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).
measure: Number of Participants With Discontinuation Due to Adverse Events (AEs)
time frame: Baseline up to 35 days after last dose of study drug (up to 29 Weeks)
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The discontinuations due to adverse events was defined for participants and reported in this outcome measure.
measure: Number of Participants With Laboratory Abnormalities
time frame: Week 1 to Week 12, Week 13 to Week 24
description: The laboratory abnormality parameters included Hematology: erythrocyte (Er.) mean corpuscular volume, Er. mean corpuscular hemoglobin:<0.9*lower limit normal (LLN), leukocytes:<0.6*LLN, lymphocytes:<0.8*LLN, neutrophils:<0.8*LLN, greater than (>) 1.2*upper limit normal (ULN), eosinophils, monocytes:>1.2*ULN. Clinical chemistry: bilirubin, direct bilirubin, indirect bilirubin:>1.5*ULN, gamma glutamyl transferase:>3.0*ULN, albumin:>1.2*ULN, blood urea nitrogen:>1.3*ULN, urate:>1.2*ULN, high-density lipoprotein (HDL) cholesterol:<0.8*LLN, potassium, magnesium:>1.1*ULN, phosphate:>1.2*ULN, bicarbonate:<0.9*LLN, creatine kinase:>2.0*ULN. Urinalysis: specific gravity:>1.030, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase:>=1.
measure: Number of Participants With Positive Anti-Recombinant Human Growth Hormone (rhGH) Antibodies and Neutralizing Antibodies (NAb)
time frame: Baseline, Week 12, Week 24
description: Blood samples were collected for determination of rhGH and NAb. The participants who tested positive for antibodies were reported.
measure: Number of Participants With Positive Anti-Somatrogon Antibodies and Neutralizing Antibodies (NAb)
time frame: Baseline, Week 12, Week 24
description: Blood samples were collected for determination of anti-somatrogon antibodies and NAb. The participants who tested positive for antibodies were reported.
arm group label: Daily to Weekly
arm group type: Other
description: Genotropin to somatrogon
arm group label: Weekly to Daily
arm group type: Other
description: somatrogon to Genotropin
intervention type: Drug
intervention name: Genotropin
description: Genotropin (dose [mg] at time of enrollment) given subcutaneously once daily
arm group label: Daily to Weekly
arm group label: Weekly to Daily
intervention type: Drug
intervention name: somatrogon
description: 0.66 mg/kg/week given subcutaneously once weekly
arm group label: Daily to Weekly
arm group label: Weekly to Daily
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Bulgaria
country: Czechia
country: Slovakia
country: United Kingdom
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C0311002
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
sharing ipd: Yes
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 url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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