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Background   Treatment of MS often begins with low-efficacy injectable disease-modifying therapy (iDMT).Objectives   To compare the effect of fingolimod 0.5 mg/day on clinical, MRI, patient-reported, and safety outcomes, in treatment-naïve and previously treated (≥1 iDMT) patients with early MS.Methods   EARLIMS was a multicentre, open-label, non-randomized, parallel-group phase 3 b/4 study in Australia and Spain. Patients with relapsing–remitting MS, Expanded Disability Status Scale (EDSS) score  1 iDMT.

Comparison of first-line and second-line use of fingolimod in relapsing MS: The open-label EARLIMS study