A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial

Table 1 Outcome assessment

Visit	Lead-in			Double-blind trial
Timescale	M-3	W-6	M0	M3	M6	M9	M12	M15	M18
ALSFRS-R	✓	✓	✓	✓	✓	✓	✓	✓	✓
ALSAQ-40 questionnaire	✓	✓	✓	✓	✓	✓	✓	✓	✓
FVC	✓	✓	✓	✓	✓	✓	✓	✓	✓
EQ-5D-5L questionnaire	✓	✓	✓	✓	✓	✓	✓	✓	✓
MRC sum-score	✓	✓	✓	✓	✓	✓	✓	✓	✓
Survival or respiratory insufficiency	✓	✓	✓	✓	✓	✓	✓	✓	✓
Blood biomarkers			✓		✓		✓		✓
CSF biomarkers			✓				✓
Safety parameters	✓	✓	✓	✓	✓	✓	✓	✓	✓

ISSN: 1745-6215