Statistical Analyses
Three analysis sets were defined: the safety analysis set, consisting
of all randomised patients who received one or more
doses of study medication, which was used for analysis of safety
variables; the full analysis set, consisting of all randomised
patients who received ≥1 dose of study medication and who
had a non-missing baseline and ≥1 post-baseline efficacy value
for ≥1 efficacy variable, which was used for analysis of efficacy
variables; and the completers analysis set, consisting of
all patients in the full analysis set who completed 104 weeks of
treatment.