Hospital Anxiety and Depression Scale

The first co-primary endpoint was the freedom of ATAF after a blanking period, and the other, uh, co-primary, um, endpoint was a change of quality of life score using, uh, the questionnaire that I was talking about, which is a twenty-item questionnaire.

The key secondary endpoints, uh, included, I'll not, uh, tell all of them, but most importantly, ATAF burden at six months and changes in psychological distress measured by a HADS score, um, uh, in addition, as I said, to several, uh, clinical outcomes.

Uh, the planned sample size was initially thirty patients.

Uh, the authors used, uh, adaptive design with interim analysis every ten patients to see if the results, uh, or if the, uh, current data need more patients in order to, to stop exactly at a moment, uh, without including more patients than needed in a, in a sham trial or sham-controlled trial.