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Table 1 Patient stratification: eligibility criteria

From: Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trial

Patient stratum Description of criteria
Pre-colectomy (Fig. 2a) • Patients with an intact colon/rectum considering prophylactic surgery
Retained rectum/ileal pouch polyposis (Fig. 2b) • Patients with ≥3 years since colectomy with IRA/proctocolectomy with pouch and demonstrating polyposis as defined by Stage 1, 2, 3a:
 − Stage 1: 10–25 polyps, all <5 mm
 − Stage 2: 10–25 polyps, at least one >1 cm
 − Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any previous evidence of high-grade dysplasia, even if completely removed
• For all patients, any rectal/pouch polyps >5 mm must be excised at baseline
Duodenal polyposis (Fig. 2c) • Patients with ≥1 of the following:
 − Current Spigelman Stage 3 or 4
 − Patients who had previous surgical endoscopic intervention ≤6 months for Spigelman Stage 3/4 that may have been down-staged to Spigelman 1/2
  1. aInSiGHT 2011 Staging System (InSiGHT Meeting, 2011, San Antonio, TX)