Trial Outcomes & Findings for Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS) (NCT NCT02954458)

Last Updated: 2025-03-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

61 participants

Primary outcome timeframe

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

Results posted on

2025-03-28

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	7	3	1	50
Overall Study COMPLETED	6	3	0	38
Overall Study NOT COMPLETED	1	0	1	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Adverse Event	0	0	1
Overall Study Withdrawal by Subject	0	0	1
Overall Study Physician Decision	0	1	1
Overall Study Lost to Follow-up	1	0	1
Overall Study Death	0	0	1
Overall Study Other	0	0	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=7 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=3 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=50 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Continuous	5.8 Years STANDARD_DEVIATION 5.43 • n=5 Participants	1.5 Years STANDARD_DEVIATION 0.80 • n=7 Participants	6.0 Years STANDARD_DEVIATION NA • n=5 Participants	5.7 Years STANDARD_DEVIATION 3.69 • n=4 Participants	5.5 Years STANDARD_DEVIATION 3.86 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	16 Participants n=4 Participants	20 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	34 Participants n=4 Participants	41 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	38 Participants n=4 Participants	42 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Race · Not allowed based on local regulations	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	35 Participants n=4 Participants	40 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not allowed based on local regulations	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=7 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=3 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=50 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	6 Participants	3 Participants	1 Participants	50 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=32 Participants 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.	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.	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.
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	2.51 mL/kg/day Standard Deviation 22.607	—	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=4 Participants 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.	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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=11 Participants 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.
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	—	15.01 mL/kg/day Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-6.87 mL/kg/day Standard Deviation 26.299

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=32 Participants 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.	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.	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.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=4 Participants 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.	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.	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.	Teduglutide/Teduglutide Treatment (TED/TED) n=14 Participants 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.
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	—	—	0.38 Stools per day Standard Deviation 1.780

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=1 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=7 Participants 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.	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.	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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-11.35 g/kg/day Standard Deviation 25.667	—	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=1 Participants 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.	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.	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.	Teduglutide/Teduglutide Treatment (TED/TED) n=4 Participants 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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—	—	-4.98 g/kg/day Standard Deviation 20.892

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=5 Participants 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.	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.	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.
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	12.16 mL/kg/day Standard Deviation 35.079	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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.	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.	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.	Teduglutide/Teduglutide Treatment (TED/TED) n=2 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=32 Participants 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.	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.	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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=4 Participants 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.	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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=14 Participants 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.
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 0.500	—	0.00 Scale on a Score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-0.08 Scale on a Score Standard Deviation 0.583

PRIMARY outcome

Timeframe: At EOS (up to 46 months)

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=40 Participants 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.	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.
Number of Participants With Positive Specific Antibodies at End of Study (EOS)	2 Participants	0 Participants	10 Participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=43 Participants 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.	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.	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.
Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment	0.087 Z-score Standard Deviation 0.422	-0.164 Z-score Standard Deviation 0.951	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=19 Participants 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.
Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)	-0.489 Z-score Standard Deviation 0.542	-0.132 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	0.013 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-0.363 Z-score Standard Deviation 0.657

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=27 Participants 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.	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.	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.
Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment	0.118 Z-score Standard Deviation 0.968	-0.277 Z-score Standard Deviation 0.797	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=18 Participants 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.
Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment	-0.518 Z-score Standard Deviation 0.451	-0.770 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	0.220 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-0.132 Z-score Standard Deviation 0.466

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=2 Participants 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.	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.	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.
Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment	—	-0.727 Z-score Standard Deviation 0.440	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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.	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.	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.	Teduglutide/Teduglutide Treatment (TED/TED) n=1 Participants 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.
Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)	—	—	—	-0.309 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=43 Participants 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.	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.	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.
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	0.035 Z-score Standard Deviation 0.904	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=19 Participants 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.
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	0.791 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-0.564 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-0.148 Z-score Standard Deviation 0.555

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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	13 Participants	—	—
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	14 Participants	—	—
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	6 Participants	—	—
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	20 Participants	—	—
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	13 Participants	—	—
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	7 Participants	—	—
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	15 Participants	—	—
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	13 Participants	—	—
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	6 Participants	—	—
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	2 Participants	—	—
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	2 Participants	—	—
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	21 Participants	—	—
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	11 Participants	—	—
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	29 Participants	—	—
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	7 Participants	—	—
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	29 Participants	—	—
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	17 Participants	—	—
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	9 Participants	—	—
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	22 Participants	—	—
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	1 Participants	—	—
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	29 Participants	—	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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	35 Participants	—	—
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	18 Participants	—	—
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	9 Participants	—	—
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	31 Participants	—	—
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	18 Participants	—	—
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	11 Participants	—	—
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	24 Participants	—	—
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	14 Participants	—	—
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	7 Participants	—	—
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	21 Participants	—	—
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	13 Participants	—	—
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	7 Participants	—	—
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	17 Participants	—	—
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	12 Participants	—	—
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	6 Participants	—	—
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	—	—
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	12 Participants	—	—
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	—	—
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	—	—
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	37 Participants	—	—
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	23 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-22.63 mL/kg/day Standard Deviation 18.125	—	—
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 10.490	-25.75 mL/kg/day Standard Deviation 22.480	—	—
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	-32.01 mL/kg/day Standard Deviation 28.837	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-32.61 mL/kg/day Standard Deviation 24.639	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-38.76 mL/kg/day Standard Deviation 21.148	—	—
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	-29.36 mL/kg/day Standard Deviation 25.514	—	—
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	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-41.88 Percent change Standard Deviation 34.100	—	—
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	-45.67 Percent change Standard Deviation 38.377	—	—
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	-46.62 Percent change Standard Deviation 37.756	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-51.28 Percent change Standard Deviation 36.364	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-58.86 Percent change Standard Deviation 33.522	—	—
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	—	—
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	-50.27 Percent change Standard Deviation 38.917	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-34.53 mL/kg/day Standard Deviation 23.849	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-37.78 mL/kg/day Standard Deviation 22.850	—	—
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	—	—
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	-26.26 mL/kg/day Standard Deviation 25.275	—	—
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	-20.87 mL/kg/day Standard Deviation 20.957	—	—
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	-24.24 mL/kg/day Standard Deviation 24.914	—	—
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	-30.53 mL/kg/day Standard Deviation 26.449	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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 12.660	-34.43 Percent Change Standard Deviation 52.810	—	—
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	-42.38 Percent Change Standard Deviation 42.375	—	—
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	-44.07 Percent Change Standard Deviation 36.002	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-52.78 Percent Change Standard Deviation 33.033	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-57.42 Percent Change Standard Deviation 34.250	—	—
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	—	—
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	-40.89 Percent Change Standard Deviation 55.305	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-17.40 kcal/kg/day Standard Deviation 13.401	—	—
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	-18.71 kcal/kg/day Standard Deviation 16.722	—	—
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	-22.09 kcal/kg/day Standard Deviation 18.009	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-24.67 kcal/kg/day Standard Deviation 18.859	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-30.20 kcal/kg/day Standard Deviation 13.754	—	—
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 20.080	—	—
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 7.540	-21.13 kcal/kg/day Standard Deviation 18.284	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-48.66 Percent change Standard Deviation 38.282	—	—
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	-46.75 Percent change Standard Deviation 38.042	—	—
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	-52.02 Percent change Standard Deviation 41.386	—	—
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	-45.91 Percent change Standard Deviation 35.484	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-53.23 Percent change Standard Deviation 37.611	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-64.30 Percent change Standard Deviation 30.289	—	—
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	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=49 Participants 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.	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.	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.
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	-15.80 kcal/kg/day Standard Deviation 17.337	—	—
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	-16.00 kcal/kg/day Standard Deviation 18.918	—	—
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	-20.18 kcal/kg/day Standard Deviation 15.633	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-24.48 kcal/kg/day Standard Deviation 15.899	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-27.83 kcal/kg/day Standard Deviation 15.311	—	—
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	—	—
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	-18.60 kcal/kg/day Standard Deviation 19.507	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=49 Participants 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.	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.	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.
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 31.100	-40.67 Percent change Standard Deviation 39.607	—	—
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	-42.75 Percent change Standard Deviation 45.563	—	—
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	-44.74 Percent change Standard Deviation 35.274	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-54.32 Percent change Standard Deviation 32.153	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-59.49 Percent change Standard Deviation 30.789	—	—
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 26.310	—	—
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	-45.84 Percent change Standard Deviation 42.242	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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	7 Participants	—	—
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	8 Participants	—	—
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	6 Participants	—	—
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	6 Participants	—	—
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	6 Participants	—	—
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	0 Participants	—	—
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	10 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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 0.990	-3.58 hours/day Standard Deviation 3.750	—	—
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	-3.55 hours/day Standard Deviation 4.497	—	—
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	-4.19 hours/day Standard Deviation 5.036	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-4.83 hours/day Standard Deviation 5.069	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-5.64 hours/day Standard Deviation 5.392	—	—
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	—	—
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 2.700	-3.89 hours/day Standard Deviation 4.881	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-33.43 Percent change Standard Deviation 35.645	—	—
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	-34.12 Percent change Standard Deviation 41.982	—	—
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	-35.11 Percent change Standard Deviation 41.822	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-40.68 Percent change Standard Deviation 42.255	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-47.07 Percent change Standard Deviation 44.248	—	—
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	—	—
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	-37.04 Percent change Standard Deviation 45.049	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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	-2.79 hours/day Standard Deviation 5.400	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-3.43 hours/day Standard Deviation 5.849	—	—
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	-2.58 hours/day Standard Deviation 5.666	—	—
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 0.000	-2.60 hours/day Standard Deviation 4.279	—	—
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	-2.78 hours/day Standard Deviation 5.479	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-3.93 hours/day Standard Deviation 6.070	—	—
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 0.000	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=49 Participants 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.	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.	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.
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 23.570	-22.75 Percent change Standard Deviation 47.101	—	—
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	-20.64 Percent change Standard Deviation 40.735	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-25.47 Percent change Standard Deviation 43.906	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-32.28 Percent change Standard Deviation 48.126	—	—
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 0.000	—	—
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 12.830	-20.91 Percent change Standard Deviation 47.918	—	—
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 0.000	-21.27 Percent change Standard Deviation 34.449	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-1.41 Days/week Standard Deviation 2.432	—	—
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	-1.76 Days/week Standard Deviation 2.508	—	—
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	-2.13 Days/week Standard Deviation 2.756	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-2.36 Days/week Standard Deviation 2.956	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-2.70 Days/week Standard Deviation 3.107	—	—
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	—	—
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	-2.14 Days/week Standard Deviation 2.720	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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	-23.40 Percent change Standard Deviation 39.994	—	—
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	-29.07 Percent change Standard Deviation 41.805	—	—
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	-31.37 Percent change Standard Deviation 41.530	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-34.66 Percent change Standard Deviation 44.475	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-39.50 Percent change Standard Deviation 47.024	—	—
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	—	—
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	-34.46 Percent change Standard Deviation 43.755	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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	-1.42 Days/week Standard Deviation 2.251	—	—
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	-1.65 Days/week Standard Deviation 2.399	—	—
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	-1.85 Days/week Standard Deviation 2.623	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-2.15 Days/week Standard Deviation 2.852	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-2.75 Days/week Standard Deviation 3.041	—	—
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	—	—
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	-1.92 Days/week Standard Deviation 2.538	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=50 Participants 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.	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.	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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-32.12 Percent change Standard Deviation 43.730	—	—
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	-23.18 Percent change Standard Deviation 36.926	—	—
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	-27.41 Percent change Standard Deviation 40.209	—	—
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	-27.58 Percent change Standard Deviation 40.258	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-40.86 Percent change Standard Deviation 46.839	—	—
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	—	—
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	-30.71 Percent change Standard Deviation 40.861	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=42 Participants 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.	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.	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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	4.69 Score on a scale Standard Deviation 22.327	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-5.80 Score on a scale Standard Deviation 27.093	—	—
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	-2.44 Score on a scale Standard Deviation 22.323	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	4.12 Score on a scale Standard Deviation 20.872	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	4.83 Score on a scale Standard Deviation 20.840	—	—
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	-2.07 Score on a scale Standard Deviation 16.807	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	0.88 Score on a scale Standard Deviation 15.249	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-0.36 Score on a scale Standard Deviation 20.680	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	1.82 Score on a scale Standard Deviation 22.811	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	1.36 Score on a scale Standard Deviation 23.674	—	—
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	0.49 Score on a scale Standard Deviation 18.262	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	5.29 Score on a scale Standard Deviation 20.484	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	2.14 Score on a scale Standard Deviation 24.662	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	3.86 Score on a scale Standard Deviation 23.193	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	2.95 Score on a scale Standard Deviation 20.458	—	—
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	—	—
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	—	—
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	—	—
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	—	—
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	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=4 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=14 Participants 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.
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	-10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	7.31 Score on a scale Standard Deviation 16.535
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	-3.13 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	31.25 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	13.56 Score on a scale Standard Deviation 22.573
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	-10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	0.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	2.50 Score on a scale Standard Deviation 23.101
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	—	0.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	3.89 Score on a scale Standard Deviation 25.954

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=43 Participants 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.	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.	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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	5.27 Score on a Scale Standard Deviation 21.637	—	—
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	1.55 Score on a Scale Standard Deviation 15.071	—	—
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	4.62 Score on a Scale Standard Deviation 18.250	—	—
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	0.20 Score on a Scale Standard Deviation 20.861	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	5.08 Score on a Scale Standard Deviation 16.152	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=3 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=15 Participants 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.
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	-27.78 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-12.50 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	6.44 Score on a scale Standard Deviation 22.648

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=2 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=39 Participants 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.	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.	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.
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	11.83 Score on a scale Standard Deviation 36.178	—	—
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	1.71 Score on a scale Standard Deviation 31.250	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	9.41 Score on a scale Standard Deviation 35.583	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	18.56 Score on a scale Standard Deviation 33.227	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	13.33 Score on a scale Standard Deviation 25.215	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	8.56 Score on a scale Standard Deviation 21.309	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	10.00 Score on a scale Standard Deviation 19.162	—	—
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	—	—
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 Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	8.57 Score on a scale Standard Deviation 23.702	—	—
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) n=4 Participants 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.	Non-teduglutide/Teduglutide Treatment (NTT/TED) n=1 Participants 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.	Teduglutide /Non-teduglutide Treatment (TED/NTT) n=1 Participants 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.	Teduglutide/Teduglutide Treatment (TED/TED) n=12 Participants 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.
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	—	3.57 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	1.70 Score on a scale Standard Deviation 19.555
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	-29.17 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	-8.33 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	5.35 Score on a scale Standard Deviation 34.013

Adverse Events

Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Non-teduglutide/Teduglutide Treatment (NTT/TED)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Teduglutide /Non-teduglutide Treatment (TED/NTT)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Teduglutide/Teduglutide Treatment (TED/TED)

Serious events: 41 serious events

Other events: 50 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER