Randomization
Patients are randomized 1:1 to receive TUDCA or placebo. After completing the lead-in period at month 0, eligible patients are randomized by means of a computerized central randomization system and coupled to a unique treatment code through an electronic platform. The randomization list has been generated using STATA software with the “ralloc” command. A permuted block randomization procedure, stratified by country, has been adopted to ensure balance across treatment groups.