Compliance
Treatment compliance was calculated on the basis of data captured on patient diaries. The number of doses administered, as a proportion of the number of doses prescribed, is expressed as a percentage. Some patients failed to maintain diaries and had to be eliminated from the analysis. In general, the number of patients with missing data was comparable across treatment groups at the various time-points for analysis in the ITT and PP populations. For analysis of compliance at the end of 12 weeks in the PP population, data was missing for 2, 3, and 0 patients in treatment groups A, B, and C, respectively. Excluding these patients, compliance was found to be 98.3%, 99.0%, and 95.9% in the 3 treatment arms, respectively.