Common use of Primary Efficacy Endpoint and Evaluations Clause in Contracts

Primary Efficacy Endpoint and Evaluations. Mean change from study Baseline (assessed at Screening) to Week 6 after the first IMP administration in the weekly number of UI episodes: • measured on a 7-day bladder diary. Seven-day bladder diaries that contain data recorded on at least 5 days will be included in the analysis. Where there are 1 or 2 days with no data, the arithmetic means will be used from the bladder diary parameters recorded on the 5 or 6 days that do have events recorded; for the days with no recorded bladder diary data.