Discussion
ALS
The TUDCA-ALS incorporates the design and the experience of the previous phase II TUDCA study [The TUDCA-ALS trial, like many clinical trials worldwide, has been significantly impacted by the COVID-19 pandemic [In the planning of sensitivity analyses, the issue of the potential impact of the pandemic on trial conduction and interpretation of results was taken into account. Special consideration is needed as some studies reported the effect of COVID-19 and of the restrictive measures on the progression of ALS [