This was an international, randomized, double-blind, multicentre,
phase III study, lasting 208weeks (4 years). The initial
52-week studywas conducted at 95 sites in 10 countries and was
followed by two extension periods, the first lasting 52weeks,
and the second lasting 104weeks (Figure S1). Core methods,
randomization and blinding procedures, as well as inclusion
and exclusion criteria, have previously been described [13].
Study sites and participants remained blinded to studymedication
throughout the entire 208-week study. Patients who completed
the first 104-week period and had given documented
informed consent were eligible to continue into the second
104-week, double-blind extension period.
This was an international, randomized, double-blind, multicentre,phase III study, lasting 208weeks (4 years). The initial52-week studywas conducted at 95 sites in 10 countries and wasfollowed by two extension periods, the first lasting 52weeks,and the second lasting 104weeks (Figure S1). Core methods,randomization and blinding procedures, as well as inclusionand exclusion criteria, have previously been described [13].Study sites and participants remained blinded to studymedicationthroughout the entire 208-week study. Patients who completedthe first 104-week period and had given documentedinformed consent were eligible to continue into the second104-week, double-blind extension period.
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