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QUESTION: In patients with a first confirmed demyelinating event, does interferon β-1a reduce the incidence of clinically definite multiple sclerosis (MS)?
Design
Randomised {allocation concealed*}†, blinded (patients, clinicians, and outcome assessors),* placebo controlled trial with 3 years of follow up (Controlled High Risk Subject Avonex Multiple Sclerosis Prevention Study [CHAMPS]). An interim analysis was planned.
Setting
50 clinical centres in North America.
Patients
383 patients (mean age 33 y, 75% women, 86% white) who had a first acute clinical demyelinating event confirmed by magnetic resonance imaging (MRI). Inclusion criteria were age 18–50 years; involvement of optic nerve, spinal cord, brain stem, or cerebellum; ≥2 clinically silent brain lesions ≥3 mm in diameter; and symptom onset <14 days from corticosteroid treatment and <27 days from …