Table 1

 Patient disposition by treatment group

Placebo (n (%))Exisulind 200 mg (n (%))Exisulind 400 mg (n (%))Total
*Patients with histologically confirmed hyperplastic polyps were excluded from the per study protocol.
†Reasons for discontinuation included adverse events, consent withdrawal, protocol violation, and other (among 155 patients with adenoma).
ITT, intention to treat.
Total No of patients enrolled959195281
Hyperplastic polyps*414342126
ITT population (adenomatous polyps only)544853155
Discontinued prematurely†11 (20.4)10 (20.8)20 (37.7)41
Efficacy evaluable population43 (79.6)38 (79.2)33 (62.3)114