Statistical analysis
Descriptive statistics for demographics and safety data were reported.Nonresponder imputation was applied to dichotomous efficacy measures for missing data. The imputed nonresponders before week 8 were considered nonresponders for all subsequent visits. Per protocol, patients with a clinically meaningful increase in corticosteroid dose were also considered nonresponders. A clinically meaningful increase was defined as an increase of at least 5 mg/day for at least 3 days of prednisone, or equivalent, or an increase of at least 3 mg/day for at least 3 days of budesonide.