Safety and Efficacy Study in Infant With SBS

Inclusion Criteria

1. Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological
age at enrollment.

2. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.

3. After major surgical resection leading to SBS, the subject has maximally 70% of
expected bowel length preserved or an ostomy in place such that ≤ 70% of the small
bowel is available for nutrient absorption.

Exclusion Criteria

1. Subject has undergone any bowel lengthening procedure.

2. Subject has a malabsorption disorder due to:

- congenital etiology (such as microvilli inclusion disease, tufting enteropathy)

- Untreated Hirchsprung's disease

3. Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or
other abnormality including EKG findings that in the opinion of the investigator makes
the infant unstable and at significant risk of not completing first 12 weeks of the
study.

4. Subjects with hyperinsulinemia.

5. Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL
within 48 hours of treatment initiation.