Primary adherence endpoints
enema
Adherence to use of each assigned product, as per-protocol, was based on the number of weeks that a participant missed using an assigned product (0 to 4 weeks), using a given product use end visit CASI assessment: “The following questions refer to your use of the study provided rectal [study product: enema, insert or suppository] over the past 4 weeks. You were asked to insert the study provided rectal [study product] in your rectum at least once a week during the past 4 weeks. However, for different reasons, people might have encountered difficulties using the [study product]. Thinking about your experience during these past four weeks, in how many of the weeks did you miss a rectal [study product] application?”. The adherence per-protocol was operationalized as binary, with participants who reported not having missed any application classified as “adherent”.Additionally, adherence per RAI-act was defined (for participant-periods with at least one RAI act was reported) as the proportion of times that participants reported having used the study-provided enema, insert or suppository before RAI. We determined adherence per RAI act by dividing participants’ responses to their CASI assessments regarding the number of times a participant noted using the study product before RAI by the total number of RAI acts self-reported over the same 4-week period. Participants are classified as fully adherent per RAI-act if they reported using the study product for all reported RAI acts.