<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/NCT02980666</url>
  </required_header>
  <id_info>
    <org_study_id>SHP633-302</org_study_id>
    <secondary_id>2020-005791-35</secondary_id>
    <nct_id>NCT02980666</nct_id>
  </id_info>
  <brief_title>Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support</brief_title>
  <official_title>A 24-week Safety, Efficacy, Pharmacodynamic, and Pharmacokinetic Study of Teduglutide in Japanese Pediatric Subjects, Aged 4 Months Through 15 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to determine if an investigational treatment (teduglutide) is&#xD;
      safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who&#xD;
      are dependent on parenteral support. This study will also evaluate how teduglutide moves&#xD;
      through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">January 21, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT)</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT)</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT)</measure>
    <time_frame>EOT (up to Week 24)</time_frame>
    <description>Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT)</measure>
    <time_frame>EOT (up to Week 24)</time_frame>
    <description>Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Achieved Greater Than or Equal to (&gt;=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28</measure>
    <time_frame>Week 28</time_frame>
    <description>Number of participants who achieved &gt;= 20% reduction in PS volume at Week 28 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Absolute change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Percent change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Absolute change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Percent change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Absolute change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Percent change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Absolute change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Percent change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Absolute change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data</measure>
    <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
    <description>Percent change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in number of hours per day of PS Usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>Absolute change from baseline in number of days per Week of PS usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
    <description>An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Body Weight for Age Z-score at Week 28</measure>
    <time_frame>Baseline, Week 28</time_frame>
    <description>Body weight was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score at Week 28 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height for Age Z-score at Week 28</measure>
    <time_frame>Baseline, Week 28</time_frame>
    <description>Height was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score at Week 28 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Head Circumference for Age Z-score at Week 28</measure>
    <time_frame>Baseline, Week 28</time_frame>
    <description>Head circumference was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference for age Z-score at Week 28 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
    <description>Vital sign assessments included pulse rate, blood pressure, or body temperature. Number of participants with clinically significant changes in vital signs by the investigator were recorded as TEAEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
    <description>12-lead ECG was performed. Any change in ECG assessments which were deemed to be clinically significant changes were recorded as TEAEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
    <description>Clinical laboratory assessments included biochemistry, hematology, coagulation, urinalysis. The number of participants with clinically significant laboratory abnormalities were reported as TEAEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in the Average Urine Output at Week 28</measure>
    <time_frame>Baseline, Week 28</time_frame>
    <description>Average urine output was recorded in measured volume at Week 28 was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in the Fecal Output at Week 28</measure>
    <time_frame>Baseline, Week 28</time_frame>
    <description>Change from baseline in the fecal output (Average number of stools per day) at Week 28 was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Positive Specific Antibodies to Teduglutide</measure>
    <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
    <description>Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing</measure>
    <time_frame>Baseline, EOT (up to Week 24)</time_frame>
    <description>GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Number of participants with clinically significant abnormal findings in gastrointestinal specific testing were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse pharmacokinetics (PK) samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Clearance (CL/F) of Teduglutide</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide</measure>
    <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
    <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Short Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Teduglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teduglutide</intervention_name>
    <description>0.05 mg/kg/day SC injection once daily for 24 weeks.</description>
    <arm_group_label>Teduglutide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent by a parent or guardian prior to any study-related procedures&#xD;
&#xD;
          -  When applicable, informed assent (as deemed appropriate by the Institutional Review&#xD;
             Board) by the participant prior to any study-related procedures&#xD;
&#xD;
          -  Male or female infant 4 to &lt;12 months corrected gestational age or child or adolescent&#xD;
             aged 1 year through 15 years&#xD;
&#xD;
          -  Current history of SBS as a result of major intestinal resection (eg, due to&#xD;
             necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis)&#xD;
&#xD;
          -  Short bowel syndrome that requires PN/IV support that provides at least 30% of caloric&#xD;
             and/or fluid/electrolyte needs&#xD;
&#xD;
          -  Stable PN/IV support, defined as:&#xD;
&#xD;
        For infants 4 to &lt;12 months corrected gestational age: Inability to significantly reduce&#xD;
        PN/IV support, usually associated with minimal or no advance in enteral feeds (ie, 10% or&#xD;
        less change in PN or advance in feeds) for at least 1 month prior to and during screening,&#xD;
        as assessed by the investigator.&#xD;
&#xD;
        For children 1 to 15 years of age:&#xD;
&#xD;
        Inability to significantly reduce PN/IV support, usually associated with minimal or no&#xD;
        advance in enteral feeds (ie, 10% or less change in PN or advance in feeds) for at least 3&#xD;
        months prior to and during screening, as assessed by the investigator.&#xD;
&#xD;
        Transient instability for events such as interruption of central access or treatment of&#xD;
        sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the&#xD;
        event.&#xD;
&#xD;
        - Sexually active female participants of childbearing potential must use medically&#xD;
        acceptable methods of birth control during and for 4 weeks following the last dose of&#xD;
        investigational product.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are not expected to be able to advance oral or tube feeding regimens&#xD;
&#xD;
          -  Serial transverse enteroplasty or any other bowel lengthening procedure performed&#xD;
             within 3 months of screening&#xD;
&#xD;
          -  Known clinically significant untreated intestinal obstruction contributing to feeding&#xD;
             intolerance and inability to reduce parenteral support&#xD;
&#xD;
          -  Unstable absorption due to cystic fibrosis or other known DNA abnormalities (eg,&#xD;
             Familial Adenomatous Polyposis, Fanconi-Bickel syndrome)&#xD;
&#xD;
          -  Severe, known dysmotility syndrome such as pseudo-obstruction or persistent, severe,&#xD;
             active gastroschisis-related dysmotility; that is the primary contributing factor to&#xD;
             feeding intolerance and inability to reduce parenteral support, prior to screening.&#xD;
             Dysmotility is defined as severe if it is expected to limit the advancement of enteral&#xD;
             feeding.&#xD;
&#xD;
          -  Evidence of clinically significant obstruction on the most recent upper GI series done&#xD;
             within 6 months prior to screening.&#xD;
&#xD;
          -  Major GI surgical intervention including significant intestinal resection within 3&#xD;
             months prior to screening (insertion of feeding tube, anastomotic ulcer repair, minor&#xD;
             intestinal resections &lt;=10 centimeter (cm), or endoscopic procedure is allowed)&#xD;
&#xD;
          -  Unstable cardiac disease or congenital heart disease or cyanotic disease, with the&#xD;
             exception of participants who had undergone ventricular or atrial septal defect&#xD;
             repair, and patent ductus arteriosus (PDA) ligation&#xD;
&#xD;
          -  History of cancer or clinically significant lymphoproliferative disease, not including&#xD;
             resected cutaneous basal or squamous cell carcinoma, or in situ nonaggressive and&#xD;
             surgically resected cancer. Participants with known cancer predisposition syndrome,&#xD;
             such as juvenile polyposis or Beckwith-Wiedemann syndrome, or first degree relative&#xD;
             with early onset of GI cancer (including hepatobiliary and pancreatic cancer) will&#xD;
             also be excluded.&#xD;
&#xD;
          -  Pregnant or lactating female participants&#xD;
&#xD;
          -  Participation in a clinical study using an experimental drug (other than glutamine or&#xD;
             Omegaven) within 3 months or 5.5 half-lives of the experimental drug, whichever is&#xD;
             longer, prior to screening and for the duration of the study&#xD;
&#xD;
          -  Previous use of teduglutide or native/synthetic GLP-2&#xD;
&#xD;
          -  Previous use of glucagon-like peptide-1 analog or human growth hormone within 3 months&#xD;
             prior to screening&#xD;
&#xD;
          -  Previous use of octreotide or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3&#xD;
             months prior to screening&#xD;
&#xD;
          -  Participants with active Crohn's disease who had been treated with biological therapy&#xD;
             (eg, antitumor necrosis factor [anti-TNF]) within the 6 months prior to the screening&#xD;
             visit&#xD;
&#xD;
          -  Participants with inflammatory bowel disease (IBD) who require chronic systemic&#xD;
             immunosuppressant therapy that had been introduced or changed during the 3 months&#xD;
             prior to screening&#xD;
&#xD;
          -  More than 3 serious complications of SBS (eg, documented infection-related catheter&#xD;
             sepsis, clots, bowel obstruction, severe water-electrolyte disturbances) within 3&#xD;
             months prior to the screening visit&#xD;
&#xD;
          -  A serious complication that affects parenteral support requirements within 1 month&#xD;
             prior to or during screening, excluding uncomplicated treatment of bacteremia, central&#xD;
             line replacement/repair, or issues of similar magnitude in an otherwise stable&#xD;
             participant&#xD;
&#xD;
          -  Body weight &lt; 5 kilogram (kg) at screening and baseline visits&#xD;
&#xD;
          -  Signs of active, severe, or unstable clinically significant hepatic impairment during&#xD;
             the screening period:&#xD;
&#xD;
        For infants 4 to &lt;12 months corrected gestational age at least 2 of any of the following&#xD;
        parameters:&#xD;
&#xD;
          1. International normalized ratio (INR) &gt;1.5 not corrected with parenteral vitamin K&#xD;
&#xD;
          2. Platelet count &lt;100×10^3/ (microliters)mcL due to portal hypertension&#xD;
&#xD;
          3. Presence of clinically significant gastric or esophageal varices&#xD;
&#xD;
          4. Documented cirrhosis&#xD;
&#xD;
          5. Persistent cholestasis defined as conjugated bilirubin &gt;4 milligram per deciliter&#xD;
             (mg/dL) (&gt;68 micromoles per liter [mcmol/L]) over a 2 week period&#xD;
&#xD;
        For children 1 to 15 years of age:&#xD;
&#xD;
          1. Total bilirubin &gt;= 2x upper limit of normal (ULN)&#xD;
&#xD;
          2. Aspartate aminotransferase (AST) &gt;= 7x ULN&#xD;
&#xD;
          3. Alanine aminotransferase (ALT) &gt;= 7x ULN&#xD;
&#xD;
               -  Signs of known continuous active or unstable, clinically significant renal&#xD;
                  dysfunction shown by results of an estimated glomerular filtration rate below 50&#xD;
                  milliliter per minute (mL/min)/1.73 meter (m)^2&#xD;
&#xD;
               -  Parent(s)/guardian(s) and/or participants who are not capable of understanding or&#xD;
                  not willing to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
               -  Unstable, clinically significant, active, untreated pancreatic or biliary disease&#xD;
&#xD;
               -  Any condition, disease, illness, or circumstance that in the investigator's&#xD;
                  opinion puts the participant at any undue risk, prevents completion of the study,&#xD;
                  or interferes with analysis of the study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Shire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka-ken</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tsukuba University Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki-Ken</state>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima University</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima-Ken</state>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi-Ken</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo-To</state>
        <zip>142-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>December 7, 2020</results_first_submitted>
  <results_first_submitted_qc>January 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2021</results_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</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>Short Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Teduglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).</ipd_description>
  </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>June 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT02980666/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 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT02980666/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 6 centers in Japan between 13 January 2017 (first participant first visit) and 21 January 2020 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 10 Japanese study participants were enrolled into the study, including 8 children ages 1 through 15 years of age and 2 infants aged 4 months through &lt; 12 months of corrected gestational age. All the participants received treatment and completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Total Children (Aged: 1 to 15 Years)</title>
          <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
        </group>
        <group group_id="P2">
          <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
          <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
              </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>Intention-to-treat (ITT) population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Total Children (Aged: 1 to 15 Years)</title>
          <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
        </group>
        <group group_id="B2">
          <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
          <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</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="8"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
          <units>mL/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.8" spread="8.47"/>
                    <measurement group_id="O2" value="-26.2" spread="13.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
          <units>Percent Change</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.7" spread="31.79"/>
                    <measurement group_id="O2" value="-26.7" spread="15.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.</population>
          <units>kcal/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" spread="8.70"/>
                    <measurement group_id="O2" value="-13.8" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>Percent change</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.2" spread="33.00"/>
                    <measurement group_id="O2" value="-25.7" spread="2.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT)</title>
        <description>Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT)</title>
          <description>Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
          <units>Micromoles per liter (mcmol/L)</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="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="4.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT)</title>
        <description>Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT)</title>
          <description>Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
          <units>Percent change</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="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2" spread="39.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>mL/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="7.14"/>
                    <measurement group_id="O2" value="0.6" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" spread="111.01"/>
                    <measurement group_id="O2" value="-23.2" spread="36.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>kcal/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="5.60"/>
                    <measurement group_id="O2" value="0.3" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" spread="117.88"/>
                    <measurement group_id="O2" value="-24.2" spread="38.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24</title>
        <description>Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24</title>
          <description>Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the 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="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT)</title>
        <description>Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT)</title>
          <description>Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT)</title>
        <description>Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT)</title>
          <description>Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Achieved Greater Than or Equal to (&gt;=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28</title>
        <description>Number of participants who achieved &gt;= 20% reduction in PS volume at Week 28 was reported.</description>
        <time_frame>Week 28</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved Greater Than or Equal to (&gt;=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28</title>
          <description>Number of participants who achieved &gt;= 20% reduction in PS volume at Week 28 was reported.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data</title>
        <description>Absolute change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data</title>
          <description>Absolute change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>mL/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="7.06"/>
                    <measurement group_id="O2" value="-3.8" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data</title>
        <description>Percent change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data</title>
          <description>Percent change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="19.59"/>
                    <measurement group_id="O2" value="-5.5" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
        <description>Absolute change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
          <description>Absolute change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>kcal/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="6.16"/>
                    <measurement group_id="O2" value="-4.0" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
        <description>Percent change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
          <description>Percent change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="19.17"/>
                    <measurement group_id="O2" value="-10.3" spread="4.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)</title>
        <description>Absolute change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)</title>
          <description>Absolute change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
          <units>Micromoles (mcM)</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="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)</title>
        <description>Percent change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)</title>
          <description>Percent change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants.</population>
          <units>Percent change</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="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.0" spread="24.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data</title>
        <description>Absolute change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data</title>
          <description>Absolute change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>mL/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.24"/>
                    <measurement group_id="O2" value="-2.8" spread="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data</title>
        <description>Percent change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data</title>
          <description>Percent change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.1" spread="28.06"/>
                    <measurement group_id="O2" value="-1.4" spread="8.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
        <description>Absolute change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
          <description>Absolute change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>kcal/kg/day</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="2.64"/>
                    <measurement group_id="O2" value="-1.4" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
        <description>Percent change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>EOT (up to Week 24), EOS (up to Week 28)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data</title>
          <description>Percent change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.1" spread="28.16"/>
                    <measurement group_id="O2" value="-3.0" spread="6.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Absolute change from baseline in number of hours per day of PS Usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Absolute change from baseline in number of hours per day of PS Usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>Hours per day (hours/day)</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="4.16"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data</title>
        <description>Absolute change from baseline in number of days per Week of PS usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data</title>
          <description>Absolute change from baseline in number of days per Week of PS usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.</description>
          <population>ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study.</population>
          <units>Days per week</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.47"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product.</description>
        <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Body Weight for Age Z-score at Week 28</title>
        <description>Body weight was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score at Week 28 was reported.</description>
        <time_frame>Baseline, Week 28</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight for Age Z-score at Week 28</title>
          <description>Body weight was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score at Week 28 was reported.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
          <units>Z-score</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.177" spread="0.3625"/>
                    <measurement group_id="O2" value="2.332" spread="1.1503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Height for Age Z-score at Week 28</title>
        <description>Height was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score at Week 28 was reported.</description>
        <time_frame>Baseline, Week 28</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height for Age Z-score at Week 28</title>
          <description>Height was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score at Week 28 was reported.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
          <units>Z-score</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.024" spread="0.4841"/>
                    <measurement group_id="O2" value="1.056" spread="0.6968"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Head Circumference for Age Z-score at Week 28</title>
        <description>Head circumference was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference for age Z-score at Week 28 was reported.</description>
        <time_frame>Baseline, Week 28</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Data for this outcome measure was not planned to be collected and analyzed for Total Children (Aged: 1 to 15 Years).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Head Circumference for Age Z-score at Week 28</title>
          <description>Head circumference was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference for age Z-score at Week 28 was reported.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Data for this outcome measure was not planned to be collected and analyzed for Total Children (Aged: 1 to 15 Years).</population>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.559" spread="0.6116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)</title>
        <description>Vital sign assessments included pulse rate, blood pressure, or body temperature. Number of participants with clinically significant changes in vital signs by the investigator were recorded as TEAEs.</description>
        <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)</title>
          <description>Vital sign assessments included pulse rate, blood pressure, or body temperature. Number of participants with clinically significant changes in vital signs by the investigator were recorded as TEAEs.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Primary</type>
        <title>Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)</title>
        <description>12-lead ECG was performed. Any change in ECG assessments which were deemed to be clinically significant changes were recorded as TEAEs.</description>
        <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)</title>
          <description>12-lead ECG was performed. Any change in ECG assessments which were deemed to be clinically significant changes were recorded as TEAEs.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Primary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)</title>
        <description>Clinical laboratory assessments included biochemistry, hematology, coagulation, urinalysis. The number of participants with clinically significant laboratory abnormalities were reported as TEAEs.</description>
        <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)</title>
          <description>Clinical laboratory assessments included biochemistry, hematology, coagulation, urinalysis. The number of participants with clinically significant laboratory abnormalities were reported as TEAEs.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Primary</type>
        <title>Change From Baseline in the Average Urine Output at Week 28</title>
        <description>Average urine output was recorded in measured volume at Week 28 was recorded.</description>
        <time_frame>Baseline, Week 28</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Average Urine Output at Week 28</title>
          <description>Average urine output was recorded in measured volume at Week 28 was recorded.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>mL/kg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.317" spread="34.8252"/>
                    <measurement group_id="O2" value="-48.879" spread="NA">Standard deviation was not estimated as only single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Fecal Output at Week 28</title>
        <description>Change from baseline in the fecal output (Average number of stools per day) at Week 28 was recorded.</description>
        <time_frame>Baseline, Week 28</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Fecal Output at Week 28</title>
          <description>Change from baseline in the fecal output (Average number of stools per day) at Week 28 was recorded.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.</population>
          <units>Average number of stools per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.64" spread="1.547"/>
                    <measurement group_id="O2" value="2.50" spread="NA">Standard deviation was not estimated as only single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Positive Specific Antibodies to Teduglutide</title>
        <description>Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.</description>
        <time_frame>From start of study drug administration up to EOS (up to Week 28)</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Specific Antibodies to Teduglutide</title>
          <description>Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.</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="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing</title>
        <description>GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Number of participants with clinically significant abnormal findings in gastrointestinal specific testing were reported.</description>
        <time_frame>Baseline, EOT (up to Week 24)</time_frame>
        <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Data for this outcome was not planned to be collected and analyzed for infants.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing</title>
          <description>GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Number of participants with clinically significant abnormal findings in gastrointestinal specific testing were reported.</description>
          <population>Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Data for this outcome was not planned to be collected and analyzed for infants.</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="8"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma</title>
        <description>Since only 2 sparse pharmacokinetics (PK) samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma</title>
          <description>Since only 2 sparse pharmacokinetics (PK) samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma</title>
        <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma</title>
          <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma</title>
        <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma</title>
          <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma</title>
        <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma</title>
          <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma</title>
        <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma</title>
          <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Clearance (CL/F) of Teduglutide</title>
        <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL/F) of Teduglutide</title>
          <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide</title>
        <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
        <time_frame>Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose</time_frame>
        <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
            <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide</title>
          <description>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</description>
          <population>Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to end of the study (up to Week 28)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Total Children (Aged: 1 - 15 Years)</title>
          <description>Participants aged from 1 through 15 years received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
        </group>
        <group group_id="E2">
          <title>Infants (Corrected Gestational Age: 4 to &lt; 12 Months)</title>
          <description>Participants (Infants) from 4 through &lt; 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device damage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="8" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site granuloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="9" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="12" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Frostbite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrostomy tube site complication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperlipasaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperzincaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device damage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </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>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@shire.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/NCT02980666
org study id: SHP633-302
secondary id: 2020-005791-35
nct id: NCT02980666
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if an investigational treatment (teduglutide) is
      safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who
      are dependent on parenteral support. This study will also evaluate how teduglutide moves
      through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day.
measure: Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).
measure: Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT)
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT)
time frame: Baseline, EOT (up to Week 24)
description: Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24
time frame: Week 24
description: Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported.
measure: Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT)
time frame: EOT (up to Week 24)
description: Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT)
time frame: EOT (up to Week 24)
description: Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Number of Participants Who Achieved Greater Than or Equal to (>=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28
time frame: Week 28
description: Number of participants who achieved >= 20% reduction in PS volume at Week 28 was reported.
measure: Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Absolute change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Percent change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Absolute change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Percent change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Absolute change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS)
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Percent change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Absolute change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Percent change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Absolute change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data
time frame: EOT (up to Week 24), EOS (up to Week 28)
description: Percent change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in number of hours per day of PS Usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data
time frame: Baseline, EOT (up to Week 24)
description: Absolute change from baseline in number of days per Week of PS usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to EOS (up to Week 28)
description: An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product.
measure: Change From Baseline in Body Weight for Age Z-score at Week 28
time frame: Baseline, Week 28
description: Body weight was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score at Week 28 was reported.
measure: Change From Baseline in Height for Age Z-score at Week 28
time frame: Baseline, Week 28
description: Height was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score at Week 28 was reported.
measure: Change From Baseline in Head Circumference for Age Z-score at Week 28
time frame: Baseline, Week 28
description: Head circumference was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference for age Z-score at Week 28 was reported.
measure: Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to EOS (up to Week 28)
description: Vital sign assessments included pulse rate, blood pressure, or body temperature. Number of participants with clinically significant changes in vital signs by the investigator were recorded as TEAEs.
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to EOS (up to Week 28)
description: 12-lead ECG was performed. Any change in ECG assessments which were deemed to be clinically significant changes were recorded as TEAEs.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to EOS (up to Week 28)
description: Clinical laboratory assessments included biochemistry, hematology, coagulation, urinalysis. The number of participants with clinically significant laboratory abnormalities were reported as TEAEs.
measure: Change From Baseline in the Average Urine Output at Week 28
time frame: Baseline, Week 28
description: Average urine output was recorded in measured volume at Week 28 was recorded.
measure: Change From Baseline in the Fecal Output at Week 28
time frame: Baseline, Week 28
description: Change from baseline in the fecal output (Average number of stools per day) at Week 28 was recorded.
measure: Number of Participants With Positive Specific Antibodies to Teduglutide
time frame: From start of study drug administration up to EOS (up to Week 28)
description: Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.
measure: Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing
time frame: Baseline, EOT (up to Week 24)
description: GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Number of participants with clinically significant abnormal findings in gastrointestinal specific testing were reported.
measure: Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse pharmacokinetics (PK) samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
measure: Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
measure: Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
measure: Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
measure: Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
measure: Apparent Clearance (CL/F) of Teduglutide
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
measure: Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide
time frame: Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose
description: Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study.
arm group label: Teduglutide
arm group type: Experimental
description: Participants will receive teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks.
intervention type: Drug
intervention name: Teduglutide
description: 0.05 mg/kg/day SC injection once daily for 24 weeks.
arm group label: Teduglutide
criteria: 
gender: All
minimum age: 4 Months
maximum age: 15 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Shire
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Short Bowel Syndrome
mesh term: Syndrome
mesh term: Teduglutide
sharing ipd: No
ipd description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 