Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study

Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte
concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline
characteristics collected included BMI and cystic fibrosis related diabetes.

Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition
regimen with pancreatic enzyme replacement therapy (PERT).

Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal
volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.

Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume
of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening
measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90.
PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI
symptom diaries and systematic assessments of adverse events and unanticipated adverse device
effects.

Inclusion Criteria:

1. Confirmed diagnosis of cystic fibrosis

2. Documented history of exocrine pancreatic insufficiency

3. Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat
diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5

4. Written informed consent or assent.

Exclusion Criteria:

1. Uncontrolled diabetes mellitus

2. Signs and symptoms of liver cirrhosis or portal hypertension

3. Lung or liver transplant

4. Active cancer currently receiving cancer treatment

5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance,
inflammatory bowel disease