<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/NCT03268811</url>
  </required_header>
  <id_info>
    <org_study_id>SHP633-305</org_study_id>
    <secondary_id>2021-005404-36</secondary_id>
    <nct_id>NCT03268811</nct_id>
  </id_info>
  <brief_title>A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302</brief_title>
  <official_title>A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects With Short Bowel Syndrome Who Completed SHP633-302</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical study is to evaluate the long-term safety and tolerability of&#xD;
      teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who&#xD;
      completed Study SHP633-302 (NCT02980666).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">November 2, 2021</completion_date>
  <primary_completion_date type="Actual">November 2, 2021</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>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From Baseline up to follow-up (up to 50 months)</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 (IP) in the core study (SHP633-302 [NCT02980666]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormalities in Vital Signs</measure>
    <time_frame>From Baseline up to follow-up (up to 50 months)</time_frame>
    <description>Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters</measure>
    <time_frame>From Baseline up to follow-up (up to 50 months)</time_frame>
    <description>Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). A negative change from baseline indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</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). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Body weight was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 1 (up to 24 Weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 2 (up to 48 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 3 (up to 72 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 4 (up to 96 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 5 (up to 120 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 6 (up to 144 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 7 (up to 168 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 8 (up to 192 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 9 (up to 196 weeks)</time_frame>
    <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 1 (up to 24 weeks)</time_frame>
    <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 2 (up to 48 weeks)</time_frame>
    <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 3 (up to 72 weeks)</time_frame>
    <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 4 (up to 76 weeks)</time_frame>
    <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 1 (up to 24 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 2 (up to 48 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 3 (up to 72 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 4 (up to 96 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 5 (up to 120 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 6 (up to 144 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 7 (up to 168 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 8 (up to 192 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of Cycle 9 (up to 196 weeks)</time_frame>
    <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized diary PS values from baseline was calculated using the formula: % reduction in PS value at the visit = ([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized prescribed PS values from baseline was calculated using the formula: % reduction in PS value at the visit =([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in Investigator prescribed PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Enteral autonomy (completely weaned off PS) was defined as the first visit where there is no use of PS for the 7 days prior to the visit and there is no prescribed PS at that visit, and the participants remains off PS for the remainder of the treatment period of that cycle. Number of participants who achieved enteral autonomy off PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment</measure>
    <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
    <description>Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days Per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</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 (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24-week intervals. If a participant deteriorates during a follow-up period, the participant may be evaluated immediately for additional teduglutide treatment (24-week interval) until teduglutide is commercially available for each participant, the participant's participation in this study is discontinued, or the study is discontinued.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teduglutide</intervention_name>
    <description>Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.</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 [IRB]) by the participant prior to any study-related procedures.&#xD;
&#xD;
          -  Participant completed Study SHP633-302 (NCT02980666).&#xD;
&#xD;
          -  Participant (and/or parent/guardian) understands and is willing and able to fully&#xD;
             adhere to study requirements as defined in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There are no exclusion criteria for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>Akita University Hospital</name>
      <address>
        <city>Akita-shi</city>
        <state>Akita-ken</state>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <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 Hospital</name>
      <address>
        <city>Kagoshima</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 Hospital</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo-To</state>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b5fd94db2bf003ab470dd</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <results_first_submitted>April 26, 2022</results_first_submitted>
  <results_first_submitted_qc>April 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2022</results_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 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>November 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03268811/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>July 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03268811/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 from 23 August 2017 (first participant first visit) and 02 November 2021 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 9 Japanese pediatric participants who completed Study SHP633-302 (NCT02980666) were enrolled into the extension study based on age of participants i.e., 7 children (aged 1 through 15 years of age) and 2 infants (aged 4 months through &lt; 12 months of corrected gestational age).</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</population>
      <group_list>
        <group group_id="B1">
          <title>Total Children (Aged: 1 to 15 Years)</title>
          <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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="7"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Aged: 1 to 15 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aged: 4 to &lt; 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </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="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </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="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </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>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 (IP) in the core study (SHP633-302 [NCT02980666]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>From Baseline up to follow-up (up to 50 months)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 (IP) in the core study (SHP633-302 [NCT02980666]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</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="7"/>
                    <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 Abnormalities in Vital Signs</title>
        <description>Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>From Baseline up to follow-up (up to 50 months)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormalities in Vital Signs</title>
          <description>Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</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="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 Abnormalities in Laboratory Parameters</title>
        <description>Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>From Baseline up to follow-up (up to 50 months)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle (Cycles 1 to 9 [Each cycle=28 weeks]) depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters</title>
          <description>Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).</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>
              <title>Biochemistry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinalysis.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment</title>
        <description>Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment</title>
          <description>Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.228" spread="42.9396"/>
                    <measurement group_id="O2" value="146.881" spread="295.8061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment</title>
        <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment</title>
          <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.37" spread="63.623"/>
                    <measurement group_id="O2" value="50.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment</title>
        <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment</title>
          <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.678" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                    <measurement group_id="O2" value="206.017" spread="332.4580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment</title>
        <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, &quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment</title>
          <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, &quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</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="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="3.143" spread="145.8659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment</title>
        <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). A negative change from baseline indicates improvement.</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment</title>
          <description>Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). A negative change from baseline indicates improvement.</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.51" spread="16.758"/>
                    <measurement group_id="O2" value="0.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment</title>
        <description>Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;overall number of participants analyzed&quot; refer to the participants evaluable for this outcome measure and &quot;number analyzed&quot; refer to participants evaluable for this outcome at given categories. &quot;0&quot; in number analyzed signifies that no participant was evaluable for specified category for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment</title>
          <description>Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;overall number of participants analyzed&quot; refer to the participants evaluable for this outcome measure and &quot;number analyzed&quot; refer to participants evaluable for this outcome at given categories. &quot;0&quot; in number analyzed signifies that no participant was evaluable for specified category for the specified group.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive ADA at EOT of the Last Cycle</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive NAbs at EOT of the Last Cycle</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Changes 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). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes 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). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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="6"/>
                <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 Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment</title>
        <description>Body weight was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment</title>
          <description>Body weight was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.229" spread="0.5636"/>
                    <measurement group_id="O2" value="3.982" spread="3.6363"/>
                  </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 EOT of Cycle 1 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 1 (up to 24 Weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002" spread="0.6049"/>
                    <measurement group_id="O2" value="1.376" spread="0.3363"/>
                  </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 EOT of Cycle 2 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 2 (up to 48 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="6"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.152" spread="0.5181"/>
                    <measurement group_id="O2" value="3.114" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 3 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 3 (up to 72 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="6"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.098" spread="0.3467"/>
                    <measurement group_id="O2" value="3.554" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 4 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 4 (up to 96 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were 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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="5"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.126" spread="0.2622"/>
                    <measurement group_id="O2" value="3.542" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 5 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 5 (up to 120 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</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="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.342" spread="0.1012"/>
                  </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 EOT of Cycle 6 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 6 (up to 144 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle (Cycles 1 to 9 [Each cycle=28 weeks]) depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</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="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.276" spread="0.2593"/>
                  </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 EOT of Cycle 7 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 7 (up to 168 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.570" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 8 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 8 (up to 192 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.851" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 9 During Teduglutide Treatment</title>
        <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 9 (up to 196 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment</title>
          <description>Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here,&quot;0&quot; in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group.</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.477" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 1 During Teduglutide Treatment</title>
        <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 1 (up to 24 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with less than (&lt;) 12 months of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment</title>
          <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with less than (&lt;) 12 months of age.</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="2.400" spread="0.6472"/>
                  </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 EOT of Cycle 2 During Teduglutide Treatment</title>
        <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 2 (up to 48 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with &lt; 12 months of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment</title>
          <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with &lt; 12 months of age.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.431" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 3 During Teduglutide Treatment</title>
        <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 3 (up to 72 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with &lt; 12 months of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment</title>
          <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with &lt; 12 months of age.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.080" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </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 EOT of Cycle 4 During Teduglutide Treatment</title>
        <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 4 (up to 76 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with &lt; 12 months of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment</title>
          <description>Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with &lt; 12 months of age.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.055" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 1 (up to 24 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants greater than or equal to (&gt;=) 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants greater than or equal to (&gt;=) 2 years of age.</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="6"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.090" spread="0.6642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 2 (up to 48 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="6"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.489" spread="0.8474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 3 (up to 72 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="6"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.409" spread="1.1688"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 4 (up to 96 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.118" spread="0.8827"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 5 (up to 120 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.070" spread="0.9770"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 6 (up to 144 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.925" spread="0.2556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 7 (up to 168 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.839" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 8 (up to 192 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.015" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment</title>
        <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of Cycle 9 (up to 196 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment</title>
          <description>BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age &gt;= 2 years old) and World Health Organization (age &lt; 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, &quot;Overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants &gt;= 2 years of age.</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.480" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized diary PS values from baseline was calculated using the formula: % reduction in PS value at the visit = ([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized diary PS values from baseline was calculated using the formula: % reduction in PS value at the visit = ([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized prescribed PS values from baseline was calculated using the formula: % reduction in PS value at the visit =([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in Investigator prescribed PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized prescribed PS values from baseline was calculated using the formula: % reduction in PS value at the visit =([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in Investigator prescribed PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 20% Reduction: At EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.5" spread="11.83"/>
                    <measurement group_id="O2" value="-31.9" spread="16.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.5" spread="14.38"/>
                    <measurement group_id="O2" value="-54.2" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.1" spread="18.19"/>
                    <measurement group_id="O2" value="-62.8" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.2" spread="24.10"/>
                    <measurement group_id="O2" value="-95.8" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.8" spread="26.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-63.8" spread="31.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-93.8" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-80.3" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-79.1" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent change at EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.6" spread="34.86"/>
                    <measurement group_id="O2" value="-32.5" spread="18.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.3" spread="33.11"/>
                    <measurement group_id="O2" value="-56.6" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52.8" spread="28.54"/>
                    <measurement group_id="O2" value="-65.6" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-62.9" spread="26.18"/>
                    <measurement group_id="O2" value="-100.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.9" spread="5.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-75.7" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.9" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-70.9" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-69.8" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.9" spread="11.06"/>
                    <measurement group_id="O2" value="-31.3" spread="26.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.0" spread="13.51"/>
                    <measurement group_id="O2" value="-60.6" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.8" spread="21.13"/>
                    <measurement group_id="O2" value="-67.5" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.3" spread="23.52"/>
                    <measurement group_id="O2" value="-98.7" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.3" spread="26.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-63.6" spread="32.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-91.8" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.3" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.9" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent change at EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.8" spread="35.19"/>
                    <measurement group_id="O2" value="-32.1" spread="26.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.9" spread="30.42"/>
                    <measurement group_id="O2" value="-61.4" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.4" spread="27.78"/>
                    <measurement group_id="O2" value="-68.3" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-62.5" spread="26.45"/>
                    <measurement group_id="O2" value="-100.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.3" spread="5.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-76.3" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-83.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-69.9" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-70.5" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>Enteral autonomy (completely weaned off PS) was defined as the first visit where there is no use of PS for the 7 days prior to the visit and there is no prescribed PS at that visit, and the participants remains off PS for the remainder of the treatment period of that cycle. Number of participants who achieved enteral autonomy off PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>Enteral autonomy (completely weaned off PS) was defined as the first visit where there is no use of PS for the 7 days prior to the visit and there is no prescribed PS at that visit, and the participants remains off PS for the remainder of the treatment period of that cycle. Number of participants who achieved enteral autonomy off PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
          <units>Days/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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.86"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.86"/>
                    <measurement group_id="O2" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.86"/>
                    <measurement group_id="O2" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="3.13"/>
                    <measurement group_id="O2" value="-7.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment</title>
        <description>Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days Per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
        <time_frame>Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)</time_frame>
        <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Children (Aged: 1 to 15 Years)</title>
            <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment</title>
          <description>Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days Per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).</description>
          <population>The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies to participants evaluable for this outcome at given timepoints.</population>
          <units>Days/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="6"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT of Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.86"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.86"/>
                    <measurement group_id="O2" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.7" spread="40.82"/>
                    <measurement group_id="O2" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.0" spread="44.72"/>
                    <measurement group_id="O2" value="-100.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOT of Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline up to follow-up (up to 50 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Total Children (Aged: 1 to 15 Years)</title>
          <description>Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.</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="7"/>
                <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="7" subjects_at_risk="7"/>
                <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>Colonic haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <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="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="1" subjects_affected="1" subjects_at_risk="7"/>
                <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>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Beta haemolytic streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="6" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis adenovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Device damage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Central venous catheter removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" 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="7" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Strabismus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" 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="2" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <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="2" subjects_affected="2" subjects_at_risk="7"/>
                <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="5" subjects_affected="2" subjects_at_risk="7"/>
                <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="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <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>Injection site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="4" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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>Adenoviral conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="2" subjects_affected="2" subjects_at_risk="7"/>
                <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="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <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="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Auricular haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Epiphyseal injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Heat stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injury corneal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="6" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypozincaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Head banging</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <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="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin erosion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin induration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <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@takeda.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/NCT03268811
org study id: SHP633-305
secondary id: 2021-005404-36
nct id: NCT03268811
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this clinical study is to evaluate the long-term safety and tolerability of
      teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who
      completed Study SHP633-302 (NCT02980666).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: From Baseline up to follow-up (up to 50 months)
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 (IP) in the core study (SHP633-302 [NCT02980666]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
time frame: From Baseline up to follow-up (up to 50 months)
description: Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
time frame: From Baseline up to follow-up (up to 50 months)
description: Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). A negative change from baseline indicates improvement.
measure: Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment
time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Body weight was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 1 (up to 24 Weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 2 (up to 48 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 3 (up to 72 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 4 (up to 96 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 5 (up to 120 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 6 (up to 144 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 7 (up to 168 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 8 (up to 192 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 9 (up to 196 weeks)
description: Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 1 (up to 24 weeks)
description: Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 2 (up to 48 weeks)
description: Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 3 (up to 72 weeks)
description: Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 4 (up to 76 weeks)
description: Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 1 (up to 24 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 2 (up to 48 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 3 (up to 72 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 4 (up to 96 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 5 (up to 120 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 6 (up to 144 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 7 (up to 168 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 8 (up to 192 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment
time frame: Baseline, EOT of Cycle 9 (up to 196 weeks)
description: BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized diary PS values from baseline was calculated using the formula: % reduction in PS value at the visit = ([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized prescribed PS values from baseline was calculated using the formula: % reduction in PS value at the visit =([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in Investigator prescribed PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Enteral autonomy (completely weaned off PS) was defined as the first visit where there is no use of PS for the 7 days prior to the visit and there is no prescribed PS at that visit, and the participants remains off PS for the remainder of the treatment period of that cycle. Number of participants who achieved enteral autonomy off PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
measure: Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)
description: Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days Per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).
arm group label: Teduglutide
arm group type: Experimental
description: Participants will receive teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24-week intervals. If a participant deteriorates during a follow-up period, the participant may be evaluated immediately for additional teduglutide treatment (24-week interval) until teduglutide is commercially available for each participant, the participant's participation in this study is discontinued, or the study is discontinued.
intervention type: Drug
intervention name: Teduglutide
description: Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
arm group label: Teduglutide
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Shire
facility: 
facility: 
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facility: 
country: Japan
url: https://clinicaltrials.takeda.com/study-detail/5f6b5fd94db2bf003ab470dd
description: To obtain more information on the study, click here/on this link
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: 