2.5 Statistical analysis
Regarding safety, the frequencies, and proportions of possibly treatment-related adverse events (AEs) were calculated. All AEs having at least a possible relation with the study drug were described (details see supporting information). Of all AEs reported the frequency and proportion per severity category, course, outcome, and drug adjustment in response to the AE were calculated.
To test whether the occurrence of any AE changed over time, the occurrence of any AE at 1 week, 3 months and 1 year was compared to the occurrence shortly after the first administration using multilevel modelling to account for the repeated observations within patients.
Treatment compliance was estimated and categorized by treating physician: 100-80% (compliant), between 50% and 80%, or less than 50% and described per visit (n (%)).
Treatment satisfaction experienced by patients and observed by physicians (very satisfied, satisfied, unsatisfied, very unsatisfied) and treatment tolerability (very good, good, moderate, poor) were described as proportions.