Sensitivity analysis for the secondary survival endpoint
ALSFRS-R
REGRESSION, DISEASE PROGRESSION
As the pandemic may affect the survival probability, the proportional hazards assumption will be checked by visual assessment of Kaplan–Meier curves, log(− log) plots, and testing of scaled Schoenfeld residuals. If the assumption of proportional hazards between treatment groups is not verified, the ratio of restricted mean survival time between groups will be provided [Finally, due to the reduction in sample size and consequently the decrease in power, an analysis assessing the association of the survival time with the disease progression (ALSFRS-R slope) will be conducted. We will perform the Cox multivariable regression, in which the primary exposure is the slope of ALSFRS-R score. The analysis will also be repeated considering the responder status as the main exposure.