Fig. 1

Flow of patients through the study.^a3 patients did not receive treatment and were excluded from the APTS. ^b11 patients did not have valid post-baseline diaries and were excluded from the FAS; 2 further patients (in the placebo group) were excluded from the primary efficacy analysis due to having no baseline diaries, but were in the FAS for all non-diary-related endpoints. APRS = all-patients-randomized set; APTS = all-patients-treated set; FAS = full-analysis set (modified intent-to-treat)