Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02954458

Enrollment

Registered

2016-11-03

Start date

2017-01-09

Completion date

2020-11-05

Last updated

2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

Brief summary

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Interventions

DRUGTED

0.05 mg/kg SC injection once daily.

OTHERSOC

Standard safety assessments and adjustments in nutritional support.

DEVICESyringe

Teduglutide will be administered using syringe.

DEVICENeedle

Teduglutide will be administered using needle.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures. 2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24. 3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion criteria

1\. There are no

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are 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 Z-score at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are 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 Z-score at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are 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 Z-score at Last Visit During Non-Teduglutide Treatment	Baseline, Last visit in NT (up to Month 39)	Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are 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 Z-score at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of study drug administration up to follow-up (up to 46 months)	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 AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.
Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	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).
Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	Average total urine 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. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).
Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	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).
Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	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).
Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	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 total daily 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).
Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	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 total daily 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).
Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	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 ostomy output per day (mL/kg/day).
Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	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 ostomy output per day.
Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	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.
Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	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 separately 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.
Number of Participants With Positive Specific Antibodies at End of Study (EOS)	At EOS (up to 46 months)	Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.
Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment	Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are 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 Z-score at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are 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 Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Secondary

Measure	Time frame	Description
Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	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 dairy 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
Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.
Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.
Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.
Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).
Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.
Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Change from baseline in days per week of diary 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.
Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent change from baseline in days per week of diary 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.
Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.
Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	Percent 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 dairy 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.

Other

Measure	Time frame	Description
Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life
Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Baseline, Last visit in NT (up to Month 39)	PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \[8 items\], emotional \[5 items\], social \[5 items\], school \[3 items\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)	PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \[8 items\], emotional \[5 items\], social \[5 items\], school \[3 items\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Countries

Belgium, Canada, Finland, Italy, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted at 23 sites between 09 January 2017 and 05 November 2020. A total of 61 participants (children and infant) were enrolled and classified into treatment groups (NTT/NTT, NTT/TED , TED/NTT, and TED/TED) based on whether they received teduglutide in their core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] and/or during this extension study. Participants who completed their core study were eligible for this extension study.

Pre-assignment details

NTT/NTT: Participants who participated in standard of care (SOC) arm in the core study and didn't receive any TED treatment in this extension study; NTT/TED: Participants who participated in SOC arm in the core study but who subsequently received TED in this extension study; TED/NTT: Participants who received TED in the core study but didn't receive any TED treatment in this extension study; TED/TED: Participants who received TED in the core study and in this extension study.

Participants by arm

Arm	Count
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) Participants who participated in standard of care arm in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	7
Non-teduglutide/Teduglutide Treatment (NTT/TED) Participants who participated in standard of care arm in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.	3
Teduglutide /Non-teduglutide Treatment (TED/NTT) Participants who received teduglutide in the core study TEDC14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.	1
Teduglutide/Teduglutide Treatment (TED/TED) Participants who received teduglutide in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.	50
Total	61

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG003
Overall Study	Adverse Event	0	0	1
Overall Study	Death	0	0	1
Overall Study	Lost to Follow-up	1	0	1
Overall Study	Other	0	0	7
Overall Study	Physician Decision	0	1	1
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Non-teduglutide/Teduglutide Treatment (NTT/TED)	Teduglutide /Non-teduglutide Treatment (TED/NTT)	Teduglutide/Teduglutide Treatment (TED/TED)	Total	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)
Age, Continuous	1.5 Years STANDARD_DEVIATION 0.8	6.0 Years	5.7 Years STANDARD_DEVIATION 3.69	5.5 Years STANDARD_DEVIATION 3.86	5.8 Years STANDARD_DEVIATION 5.43
Race/Ethnicity, Customized Ethnicity Hispanic or Latino	1 Participants	0 Participants	10 Participants	14 Participants	3 Participants
Race/Ethnicity, Customized Ethnicity Not allowed based on local regulations	1 Participants	0 Participants	5 Participants	7 Participants	1 Participants
Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino	1 Participants	1 Participants	35 Participants	40 Participants	3 Participants
Race/Ethnicity, Customized Race American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Asian	1 Participants	0 Participants	1 Participants	3 Participants	1 Participants
Race/Ethnicity, Customized Race Black or African American	0 Participants	0 Participants	6 Participants	7 Participants	1 Participants
Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Not allowed based on local regulations	1 Participants	0 Participants	4 Participants	6 Participants	1 Participants
Race/Ethnicity, Customized Race Other	1 Participants	0 Participants	1 Participants	3 Participants	1 Participants
Race/Ethnicity, Customized Race White	0 Participants	1 Participants	38 Participants	42 Participants	3 Participants
Sex: Female, Male Female	1 Participants	0 Participants	16 Participants	20 Participants	3 Participants
Sex: Female, Male Male	2 Participants	1 Participants	34 Participants	41 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 3	0 / 1	2 / 50
other Total, other adverse events	6 / 7	3 / 3	1 / 1	50 / 50
serious Total, serious adverse events	4 / 7	2 / 3	1 / 1	41 / 50

Outcome results

Primary

Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment

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.

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment	-0.54 Scale on a Score	Standard Deviation 0.977

Primary

Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)

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 separately 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.

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)	-0.25 Scale on a Score	Standard Deviation 0.5
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)	0.00 Scale on a Score	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)	-0.08 Scale on a Score	Standard Deviation 0.583

Primary

Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment

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).

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment	-0.47 Stools per day	Standard Deviation 2.272

Primary

Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)	-0.50 Stools per day	Standard Deviation 0.913
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)	0.38 Stools per day	Standard Deviation 1.78

Primary

Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment

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 total daily 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).

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment	0.00 g/kg/day	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment	-11.35 g/kg/day	Standard Deviation 25.667

Primary

Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)

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 total daily 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).

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)	0.31 g/kg/day	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)	-4.98 g/kg/day	Standard Deviation 20.892

Primary

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 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment	-12.52 mL/kg/day	Standard Deviation 11.675
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment	12.16 mL/kg/day	Standard Deviation 35.079

Primary

Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)	23.89 mL/kg/day	Standard Deviation 37.835

Primary

Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment

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).

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment	0.26 mL/kg/day	Standard Deviation 1.692
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment	2.51 mL/kg/day	Standard Deviation 22.607

Primary

Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)

Average total urine 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. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)	-0.89 mL/kg/day	Standard Deviation 7.431
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)	15.01 mL/kg/day	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)	-6.87 mL/kg/day	Standard Deviation 26.299

Primary

Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment

BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment	0.215 Z-score	Standard Deviation 0.142
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment	0.035 Z-score	Standard Deviation 0.904

Primary

Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.545 Z-score	Standard Deviation 1.335
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)	0.791 Z-score	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.564 Z-score	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.148 Z-score	Standard Deviation 0.555

Primary

Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment

Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment	0.087 Z-score	Standard Deviation 0.422
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment	-0.164 Z-score	Standard Deviation 0.951

Primary

Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.489 Z-score	Standard Deviation 0.542
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.132 Z-score	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)	0.013 Z-score	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.363 Z-score	Standard Deviation 0.657

Primary

Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment

Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment	-0.727 Z-score	Standard Deviation 0.44

Primary

Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.309 Z-score

Primary

Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment

Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Time frame: Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment	0.118 Z-score	Standard Deviation 0.968
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment	-0.277 Z-score	Standard Deviation 0.797

Primary

Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment	-0.518 Z-score	Standard Deviation 0.451
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment	-0.770 Z-score	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment	0.220 Z-score	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment	-0.132 Z-score	Standard Deviation 0.466

Primary

Number of Participants With Positive Specific Antibodies at End of Study (EOS)

Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.

Time frame: At EOS (up to 46 months)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants With Positive Specific Antibodies at End of Study (EOS)	2 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants With Positive Specific Antibodies at End of Study (EOS)	0 Participants
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Number of Participants With Positive Specific Antibodies at End of Study (EOS)	10 Participants

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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 AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.

Time frame: From start of study drug administration up to follow-up (up to 46 months)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	3 Participants
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	1 Participants
Teduglutide/Teduglutide Treatment (TED/TED)	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	50 Participants

Secondary

Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in days per week of diary 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.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-1.50 Days/week	Standard Deviation 2.121
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-1.00 Days/week	Standard Deviation 1.732
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	0.00 Days/week	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-0.33 Days/week	Standard Deviation 0.577
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-1.00 Days/week	Standard Deviation 1.414
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	0.00 Days/week	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-1.41 Days/week	Standard Deviation 2.432
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-1.76 Days/week	Standard Deviation 2.508
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-2.13 Days/week	Standard Deviation 2.756
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-2.36 Days/week	Standard Deviation 2.956
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-2.70 Days/week	Standard Deviation 3.107
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-3.00 Days/week	Standard Deviation 2.646
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-2.14 Days/week	Standard Deviation 2.72

Secondary

Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

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 dairy 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

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-0.33 Days/week	Standard Deviation 0.577
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-1.00 Days/week	Standard Deviation 1.414
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-1.50 Days/week	Standard Deviation 2.121
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	0.00 Days/week	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-1.00 Days/week	Standard Deviation 1.732
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	0.00 Days/week	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-2.15 Days/week	Standard Deviation 2.852
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-3.00 Days/week	Standard Deviation 2.646
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-1.42 Days/week	Standard Deviation 2.251
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-2.75 Days/week	Standard Deviation 3.041
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-1.65 Days/week	Standard Deviation 2.399
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-1.92 Days/week	Standard Deviation 2.538
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-1.85 Days/week	Standard Deviation 2.623

Secondary

Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-16.95 kcal/kg/day	Standard Deviation 15.141
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-10.46 kcal/kg/day	Standard Deviation 0.023
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-20.77 kcal/kg/day	Standard Deviation 0.206
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-34.01 kcal/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-33.68 kcal/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-24.98 kcal/kg/day	Standard Deviation 7.54
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-34.46 kcal/kg/day	Standard Deviation 20.08
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-24.67 kcal/kg/day	Standard Deviation 18.859
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-17.40 kcal/kg/day	Standard Deviation 13.401
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-21.13 kcal/kg/day	Standard Deviation 18.284
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-18.71 kcal/kg/day	Standard Deviation 16.722
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-30.20 kcal/kg/day	Standard Deviation 13.754
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-22.09 kcal/kg/day	Standard Deviation 18.009

Secondary

Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-14.87 mL/kg/day	Standard Deviation 4.574
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-8.98 mL/kg/day	Standard Deviation 10.49
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-34.81 mL/kg/day	Standard Deviation 15.314
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-57.45 mL/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-56.90 mL/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-33.39 mL/kg/day	Standard Deviation 20.503
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-40.51 mL/kg/day	Standard Deviation 24.833
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-32.61 mL/kg/day	Standard Deviation 24.639
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-22.63 mL/kg/day	Standard Deviation 18.125
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-29.36 mL/kg/day	Standard Deviation 25.514
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-25.75 mL/kg/day	Standard Deviation 22.48
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-38.76 mL/kg/day	Standard Deviation 21.148
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-32.01 mL/kg/day	Standard Deviation 28.837

Secondary

Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-1.71 hours/day	Standard Deviation 2.424
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-3.05 hours/day	Standard Deviation 2.7
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-4.00 hours/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-0.57 hours/day	Standard Deviation 0.99
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-3.57 hours/day	Standard Deviation 2.222
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-4.00 hours/day	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-4.83 hours/day	Standard Deviation 5.069
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-5.64 hours/day	Standard Deviation 5.392
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-3.55 hours/day	Standard Deviation 4.497
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-4.19 hours/day	Standard Deviation 5.036
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-3.58 hours/day	Standard Deviation 3.75
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-5.14 hours/day	Standard Deviation 4.536
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-3.89 hours/day	Standard Deviation 4.881

Secondary

Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	0.00 hours/day	Standard Deviation 0
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-3.00 hours/day	Standard Deviation 4.243
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-1.00 hours/day	Standard Deviation 1.414
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-4.00 hours/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-1.33 hours/day	Standard Deviation 2.309
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-4.00 hours/day	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-3.43 hours/day	Standard Deviation 5.849
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-2.58 hours/day	Standard Deviation 5.666
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-2.60 hours/day	Standard Deviation 4.279
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-3.93 hours/day	Standard Deviation 6.07
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-2.78 hours/day	Standard Deviation 5.479
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	0.00 hours/day	Standard Deviation 0
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-2.79 hours/day	Standard Deviation 5.4

Secondary

Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-16.94 kcal/kg/day	Standard Deviation 15.187
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-37.91 kcal/kg/day	Standard Deviation 38.003
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-44.01 kcal/kg/day	Standard Deviation 27.532
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-34.59 kcal/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-34.76 kcal/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-39.68 kcal/kg/day	Standard Deviation 21.758
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-33.30 kcal/kg/day	Standard Deviation 19.205
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-24.48 kcal/kg/day	Standard Deviation 15.899
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-15.80 kcal/kg/day	Standard Deviation 17.337
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-18.60 kcal/kg/day	Standard Deviation 19.507
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-16.00 kcal/kg/day	Standard Deviation 18.918
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-27.83 kcal/kg/day	Standard Deviation 15.311
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-20.18 kcal/kg/day	Standard Deviation 15.633

Secondary

Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment

Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-22.57 mL/kg/day	Standard Deviation 13.957
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-58.82 mL/kg/day	Standard Deviation 4.022
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-65.88 mL/kg/day	Standard Deviation 12.621
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-68.72 mL/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-68.99 mL/kg/day	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-48.23 mL/kg/day	Standard Deviation 25.528
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-24.24 mL/kg/day	Standard Deviation 24.914
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-30.53 mL/kg/day	Standard Deviation 26.449
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-20.87 mL/kg/day	Standard Deviation 20.957
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6	-39.10 mL/kg/day	Standard Deviation 24.154
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-37.78 mL/kg/day	Standard Deviation 22.85
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle	-26.26 mL/kg/day	Standard Deviation 25.275
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	-34.53 mL/kg/day	Standard Deviation 23.849

Secondary

Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment

Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 3	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 5	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 2	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 6	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 4	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Last Cycle	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 1	0 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Last Cycle	10 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 1	7 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 2	8 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 3	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 4	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 5	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment	EOT of Cycle 6	0 Participants

Secondary

Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment

Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. Number of participants in each categories are mutually exhaustive at each time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1: >= 20% Reduction	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1: >= 50% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2: >= 20% Reduction	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2: >= 50% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3: >= 20% Reduction	2 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3: >= 50% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4: >= 20% Reduction	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5: >= 20% Reduction	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5: >= 50% Reduction	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6: >= 20% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6: >= 50% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle: >= 20% Reduction	3 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle: >= 50% Reduction	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle: >= 75% Reduction	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4: >= 50% Reduction	1 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4: >= 75% Reduction	7 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1: >= 20% Reduction	29 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle: >= 50% Reduction	21 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1: >= 50% Reduction	13 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5: >= 20% Reduction	15 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1: >= 75% Reduction	7 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6: >= 75% Reduction	1 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2: >= 20% Reduction	29 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5: >= 50% Reduction	13 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2: >= 50% Reduction	17 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4: >= 50% Reduction	13 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2: >= 75% Reduction	9 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5: >= 75% Reduction	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3: >= 20% Reduction	22 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle: >= 20% Reduction	29 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3: >= 50% Reduction	14 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6: >= 20% Reduction	2 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3: >= 75% Reduction	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Last Cycle: >= 75% Reduction	11 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4: >= 20% Reduction	20 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 6: >= 50% Reduction	2 Participants

Secondary

Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment

Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 2: >= 20% Reduction in PS Volume	2 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 4: >= 75% Reduction in PS Volume	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 3: >= 20% Reduction in PS Volume	2 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 5: >= 20% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 1: >= 75% Reduction in PS Volume	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 5: >= 50% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 3: >= 50% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 5: >= 75% Reduction in PS Volume	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 2: >= 50% Reduction in PS Volume	2 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 3: >= 75% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 1: >= 50% Reduction in PS Volume	0 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 4: >= 20% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Last Cycle: >= 20% Reduction in PS Volume	3 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 2: >= 75% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Last Cycle: >= 50% Reduction in PS Volume	2 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 4: >= 50% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Last Cycle: >= 75% Reduction in PS Volume	1 Participants
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 1: >= 20% Reduction in PS Volume	2 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 6: >= 75% Reduction in PS Volume	0 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Last Cycle: >= 20% Reduction in PS Volume	37 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Last Cycle: >= 50% Reduction in PS Volume	23 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Last Cycle: >= 75% Reduction in PS Volume	12 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 1: >= 20% Reduction in PS Volume	35 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 1: >= 50% Reduction in PS Volume	18 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 1: >= 75% Reduction in PS Volume	9 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 2: >= 20% Reduction in PS Volume	31 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 2: >= 50% Reduction in PS Volume	18 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 2: >= 75% Reduction in PS Volume	11 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 3: >= 20% Reduction in PS Volume	24 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 3: >= 50% Reduction in PS Volume	14 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 3: >= 75% Reduction in PS Volume	7 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 4: >= 20% Reduction in PS Volume	21 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 4: >= 50% Reduction in PS Volume	13 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 4: >= 75% Reduction in PS Volume	7 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 5: >= 20% Reduction in PS Volume	17 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 5: >= 50% Reduction in PS Volume	12 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 5: >= 75% Reduction in PS Volume	6 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 6: >= 20% Reduction in PS Volume	2 Participants
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment	EOT of Cycle 6: >= 50% Reduction in PS Volume	2 Participants

Secondary

Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent change from baseline in days per week of diary 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.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-4.76 Percent change	Standard Deviation 8.248
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-14.29 Percent change	Standard Deviation 20.203
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-21.43 Percent change	Standard Deviation 30.305
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	0.00 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	0.00 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-14.29 Percent change	Standard Deviation 24.744
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-42.86 Percent change	Standard Deviation 37.796
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-34.66 Percent change	Standard Deviation 44.475
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-23.40 Percent change	Standard Deviation 39.994
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-34.46 Percent change	Standard Deviation 43.755
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-29.07 Percent change	Standard Deviation 41.805
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-39.50 Percent change	Standard Deviation 47.024
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-31.37 Percent change	Standard Deviation 41.53

Secondary

Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent 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 dairy 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.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-4.76 Percent change	Standard Deviation 8.248
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-14.29 Percent change	Standard Deviation 20.203
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-21.43 Percent change	Standard Deviation 30.305
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	0.00 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	0.00 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-14.29 Percent change	Standard Deviation 24.744
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-42.86 Percent change	Standard Deviation 37.796
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-32.12 Percent change	Standard Deviation 43.73
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-23.18 Percent change	Standard Deviation 36.926
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-30.71 Percent change	Standard Deviation 40.861
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-27.41 Percent change	Standard Deviation 40.209
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-40.86 Percent change	Standard Deviation 46.839
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-27.58 Percent change	Standard Deviation 40.258

Secondary

Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-50.31 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-45.98 Percent change	Standard Deviation 16.836
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-35.21 Percent change	Standard Deviation 31.088
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-14.63 Percent change	Standard Deviation 1.162
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-29.03 Percent change	Standard Deviation 2.083
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-49.81 Percent change	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-45.91 Percent change	Standard Deviation 35.484
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-46.75 Percent change	Standard Deviation 38.042
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-64.30 Percent change	Standard Deviation 30.289
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-50.89 Percent change	Standard Deviation 25.667
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-48.66 Percent change	Standard Deviation 38.282
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-52.02 Percent change	Standard Deviation 41.386
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-53.23 Percent change	Standard Deviation 37.611

Secondary

Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment

Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-50.50 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-13.29 Percent change	Standard Deviation 16.826
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-50.99 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-42.65 Percent change	Standard Deviation 7.061
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-38.66 Percent change	Standard Deviation 2.603
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-23.23 Percent change	Standard Deviation 15.103
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-50.27 Percent change	Standard Deviation 38.917
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-45.67 Percent change	Standard Deviation 38.377
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-41.88 Percent change	Standard Deviation 34.1
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-46.62 Percent change	Standard Deviation 37.756
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-51.28 Percent change	Standard Deviation 36.364
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-58.86 Percent change	Standard Deviation 33.522
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-52.87 Percent change	Standard Deviation 32.722

Secondary

Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-14.29 Percent change	Standard Deviation 20.203
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-21.69 Percent change	Standard Deviation 21.433
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-22.22 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-26.98 Percent change	Standard Deviation 22.448
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-22.22 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-4.76 Percent change	Standard Deviation 8.248
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-33.43 Percent change	Standard Deviation 35.645
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-47.07 Percent change	Standard Deviation 44.248
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-34.12 Percent change	Standard Deviation 41.982
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-35.11 Percent change	Standard Deviation 41.822
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-40.68 Percent change	Standard Deviation 42.255
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-42.86 Percent change	Standard Deviation 37.796
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-37.04 Percent change	Standard Deviation 45.049

Secondary

Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	0.00 Percent change	Standard Deviation 0
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-16.67 Percent change	Standard Deviation 23.57
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-5.56 Percent change	Standard Deviation 7.857
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-22.22 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-22.22 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-7.41 Percent change	Standard Deviation 12.83
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	0.00 Percent change	Standard Deviation 0
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-25.47 Percent change	Standard Deviation 43.906
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-21.27 Percent change	Standard Deviation 34.449
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-20.91 Percent change	Standard Deviation 47.918
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-22.75 Percent change	Standard Deviation 47.101
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-32.28 Percent change	Standard Deviation 48.126
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-20.64 Percent change	Standard Deviation 40.735

Secondary

Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-34.79 Percent change	Standard Deviation 31.1
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-50.00 Percent change	Standard Deviation 47.944
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-59.00 Percent change	Standard Deviation 32.825
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-50.45 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-50.69 Percent change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-64.50 Percent change	Standard Deviation 16.117
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-50.67 Percent change	Standard Deviation 26.31
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-54.32 Percent change	Standard Deviation 32.153
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-40.67 Percent change	Standard Deviation 39.607
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-45.84 Percent change	Standard Deviation 42.242
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-42.75 Percent change	Standard Deviation 45.563
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-59.49 Percent change	Standard Deviation 30.789
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-44.74 Percent change	Standard Deviation 35.274

Secondary

Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment

Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-28.82 Percent Change	Standard Deviation 12.66
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-73.03 Percent Change	Standard Deviation 18.304
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-67.01 Percent Change	Standard Deviation 24.723
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-55.42 Percent Change	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-60.20 Percent Change	Standard Deviation 22.297
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-55.20 Percent Change	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Last Cycle	-40.89 Percent Change	Standard Deviation 55.305
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 5	-57.42 Percent Change	Standard Deviation 34.25
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 1	-34.43 Percent Change	Standard Deviation 52.81
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 6	-52.62 Percent Change	Standard Deviation 33.377
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 2	-42.38 Percent Change	Standard Deviation 42.375
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 4	-52.78 Percent Change	Standard Deviation 33.033
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment	Percent Change at EOT of Cycle 3	-44.07 Percent Change	Standard Deviation 36.002

Other Pre-specified

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment

PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \[8 items\], emotional \[5 items\], social \[5 items\], school \[3 items\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 1	-21.88 Score on a scale	Standard Deviation 8.839
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 2	-18.75 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 3	-18.75 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 4	-9.38 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 5	-15.63 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 1	-7.50 Score on a scale	Standard Deviation 10.607
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 2	5.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 3	-15.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 4	5.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 5	0.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 1	-12.50 Score on a scale	Standard Deviation 17.678
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 2	-25.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 3	-30.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 4	-15.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 5	-15.00 Score on a scale	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 2	4.69 Score on a scale	Standard Deviation 22.327
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 1	0.49 Score on a scale	Standard Deviation 18.262
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 1	-2.07 Score on a scale	Standard Deviation 16.807
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 2	5.29 Score on a scale	Standard Deviation 20.484
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 2	0.88 Score on a scale	Standard Deviation 15.249
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 5	1.36 Score on a scale	Standard Deviation 23.674
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 4	3.86 Score on a scale	Standard Deviation 23.193
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 3	2.14 Score on a scale	Standard Deviation 24.662
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 3	-5.80 Score on a scale	Standard Deviation 27.093
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Social Functioning: Change at EOT of Cycle 5	2.95 Score on a scale	Standard Deviation 20.458
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 4	4.12 Score on a scale	Standard Deviation 20.872
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	School Functioning: Change at EOT of Cycle 1	3.33 Score on a scale	Standard Deviation 25.111
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 5	4.83 Score on a scale	Standard Deviation 20.84
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	School Functioning: Change at EOT of Cycle 2	6.93 Score on a scale	Standard Deviation 27.096
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	School Functioning: Change at EOT of Cycle 3	1.17 Score on a scale	Standard Deviation 33.804
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	School Functioning: Change at EOT of Cycle 4	9.89 Score on a scale	Standard Deviation 25.233
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 3	-0.36 Score on a scale	Standard Deviation 20.68
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	School Functioning: Change at EOT of Cycle 5	8.33 Score on a scale	Standard Deviation 23.721
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Emotional Functioning: Change at EOT of Cycle 4	1.82 Score on a scale	Standard Deviation 22.811
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment	Physical Functioning: Change at EOT of Cycle 1	-2.44 Score on a scale	Standard Deviation 22.323

Other Pre-specified

Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment

PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 1	-12.50 Score on a scale	Standard Deviation 17.678
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 2	-4.17 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 3	-4.17 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 4	12.50 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 5	0.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 2	0.00 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 4	-3.57 Score on a scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 1	0.00 Score on a scale	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 5	13.33 Score on a scale	Standard Deviation 25.215
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 2	9.41 Score on a scale	Standard Deviation 35.583
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 2	10.00 Score on a scale	Standard Deviation 19.162
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 1	1.71 Score on a scale	Standard Deviation 31.25
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 3	11.49 Score on a scale	Standard Deviation 23.665
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 1	8.56 Score on a scale	Standard Deviation 21.309
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 3	11.83 Score on a scale	Standard Deviation 36.178
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 4	8.57 Score on a scale	Standard Deviation 23.702
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Food and Drink Limits: Change at EOT of Cycle 4	18.56 Score on a scale	Standard Deviation 33.227
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment	Diarrhea: Change at EOT of Cycle 5	5.56 Score on a scale	Standard Deviation 27.147

Other Pre-specified

Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)

PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: Analysis was performed using safety population. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Diarrhea: Change at Last NT	-4.46 Score on a scale	Standard Deviation 4.494
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Food and Drink Limits: Change at Last NT	-7.29 Score on a scale	Standard Deviation 32.698
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Food and Drink Limits: Change at Last NT	-29.17 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Food and Drink Limits: Change at Last NT	-8.33 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Diarrhea: Change at Last NT	3.57 Score on a scale	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Food and Drink Limits: Change at Last NT	5.35 Score on a scale	Standard Deviation 34.013
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)	Diarrhea: Change at Last NT	1.70 Score on a scale	Standard Deviation 19.555

Other Pre-specified

Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Social Functioning: Change at Last NT	0.00 Score on a scale	Standard Deviation 4.082
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Physical Functioning: Change at Last NT	3.91 Score on a scale	Standard Deviation 10.636
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	School Functioning: Change at Last NT	11.67 Score on a scale	Standard Deviation 45.369
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Emotional Functioning: Change at Last NT	-2.50 Score on a scale	Standard Deviation 15.546
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Physical Functioning: Change at Last NT	-3.13 Score on a scale	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Emotional Functioning: Change at Last NT	-10.00 Score on a scale	—
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Social Functioning: Change at Last NT	-10.00 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Social Functioning: Change at Last NT	-10.00 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	School Functioning: Change at Last NT	0.00 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Physical Functioning: Change at Last NT	31.25 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Emotional Functioning: Change at Last NT	0.00 Score on a scale	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	School Functioning: Change at Last NT	3.89 Score on a scale	Standard Deviation 25.954
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Social Functioning: Change at Last NT	7.31 Score on a scale	Standard Deviation 16.535
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Physical Functioning: Change at Last NT	13.56 Score on a scale	Standard Deviation 22.573
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)	Emotional Functioning: Change at Last NT	2.50 Score on a scale	Standard Deviation 23.101

Other Pre-specified

Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment

PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Time frame: Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	-13.19 Score on a Scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	-2.78 Score on a Scale	Standard Deviation 3.928
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	-5.56 Score on a Scale	Standard Deviation 5.893
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	2.78 Score on a Scale	—
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	-10.65 Score on a Scale	Standard Deviation 9.326
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 1	1.55 Score on a Scale	Standard Deviation 15.071
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 4	5.27 Score on a Scale	Standard Deviation 21.637
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 2	4.62 Score on a Scale	Standard Deviation 18.25
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 5	5.08 Score on a Scale	Standard Deviation 16.152
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment	Change at EOT of Cycle 3	0.20 Score on a Scale	Standard Deviation 20.861

Other Pre-specified

Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)

Time frame: Baseline, Last visit in NT (up to Month 39)

Population: The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.

Arm	Measure	Value (MEAN)	Dispersion
Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)	-3.47 Score on a scale	Standard Deviation 10.914
Non-teduglutide/Teduglutide Treatment (NTT/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)	-27.78 Score on a scale	—
Teduglutide /Non-teduglutide Treatment (TED/NTT)	Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)	-12.50 Score on a scale	—
Teduglutide/Teduglutide Treatment (TED/TED)	Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)	6.44 Score on a scale	Standard Deviation 22.648

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026

Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment

Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment

Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment

Number of Participants With Positive Specific Antibodies at End of Study (EOS)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment

Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment

Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment

Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment

Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)

Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment

Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)