Orlistat treatment resulted in decreases in weight of 2.61 kg and in BMI of 0.86. Although the latter is lower than the power goal of the study, it is within the 95% confidence interval of the difference (0.37-1.34). This improvement in BMI was similar to that observed after 1 year in 5 major placebo-controlled studies in adults (between-group BMI difference of –0.74 to –1.32 in favor of orlistat [data on file]). Compared with 15.7% of the placebo group, 26.5% of the orlistat group had a 5% or higher decrease in BMI; and 4.5% and 13.3%, respectively had a 10% or higher decrease in BMI. These values are similar to those reported in studies of obese adults without severe comorbidities in which orlistat-treated participants were up to 2.0 times more likely to experience a 5% or higher decrease in weight than placebo recipients and up to 2.5 times more likely to experience a 10% or higher decrease in weight than placebo recipients