We used two clinical outcomes in this analysis – 1) development of a new clinical relapse, and 2) confirmed disability progression. A new clinical relapse was defined as patient-reported symptoms or objectively observed signs typical for an acute inflammatory demyelinating event in the central nervous system with duration of at least 24 h, in the absence of fever or infection.  Confirmed disability progression (CDP) was defined as an increase in EDSS by 1.0 point (if baseline EDSS >0) or 1.5 points (if baseline EDSS = 0) confirmed after 6 months .