Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Time to Treatment Failure

Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following: * Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps), or * Diagnosis of colorectal malignancy (ColMal), or * Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release.

Time frame: 5 years

Total Number of Colorectal Polyps

Total number of colorectal polyps \>2 mm in size, that were detected over Years 1 - 5 cumulatively. Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps \>2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study.

Time frame: Years 1 - 5

Colorectal Polyp Burden

The polyp burden was defined as the sum of the largest diameters of all polyps (\>2 mm in size) over Years 1 - 5 cumulatively. Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study.

Time frame: Years 1 - 5