Table 1.

Timing and guidance for stage 1 and stage 2 analyses

Stage	Number of pwALS/arm excluding long survivors	Criterion to continue to next stage
Stage 1	50 with ≥6 months of follow-up	95% CI of the rate of change in ALSFRS-R compared with placebo must include a relative improvement of 25% in the rate of decline
Stage 2	100 with ≥12 months of follow-up	Improvement in rate of change in ALSFRS-R compared with placebo significant at pairwise one-sided 10% level

ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale Revised; pwALS, people with ALS.