Outcomes
ALSFRS-R
REGRESSION, SECONDARY
The primary outcome is measured through the identification of the responder patients, defined as those showing an improvement of at least 20% in the ALSFRS-R slope during the 18-month randomization period compared to the 3-month lead-in period. Slope coefficients for ALSFRS-R decline will be calculated separately for the lead-in period and the treatment period using the linear regression model.The secondary efficacy outcomes are presented in Table Secondary and exploratory outcomes