The composite efficacy end point was response, evaluated
at weeks 1 through 12 (FDA primary end point)
and weeks 1 through 26 (European Medicines Agency
primary end point). Responders were defined as having
an improvement in daily pain (WAP scores improved by ≥ 30% in the past 24 hours compared with average baseline
pain) and daily stool consistency (BSS score < 5) on
at least 50% of days.