4.12. Data analysis
All analyses will be conducted on an intention-to-treat
basis (random effect negative binomial regression and random effect mixed models). If patients have less than three months of complete diary data over the course of the year they will be excluded from the analysis of the daily diaries. Differences in baseline characteristics between the intervention and control
group will be analysed using common statistical procedures, such as chi-squared tests, T-tests and Mann–Whitney U tests, as appropriate.