Subgroup analyses
ALS
DISEASE
Exploratory subgroup analyses will be performed for the primary outcome in the ITT population, according to the following subgroup variables measured at randomization (month 0): site of onset, type of ALS (familial, sporadic), age (categorized according to the median), duration of the disease since symptom onset (categorized according to the median), gender, country. Moreover, an exploratory analysis will be conducted stratifying patients according to neurofilaments level [