Seven secondary endpoints were defi

Seven secondary endpoints were defined a priori and tested using a hierarchical approach. In Study MPUC3003, only the first secondary endpoint, the number and proportion of patients in each level of change from baseline in rectal bleeding score at months 1, 3, and 6, was found to have a statistically significant difference between the eMG and placebo groups (p-0.008). In Study MPUC3004, a statistically significant difference between eMG and placebo groups was not found for any of the secondary endpoints. Once a secondary endpoint failed to reach statistical significance, further endpoints in the hierarchy were deemed exploratory (and not inferential) in nature.,