Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial

The primary efficacy outcome was the change in ALSFRS-R score from the baseline to 24 weeks (or at discontinuation if this was after the third cycle) after randomisation and the least-squares mean difference between groups was 2·49 (SE 0·76, 95% CI 0·99-3·98) in favour of edaravone.