Safety Outcomes
deaths, psychiatric, self-harm
EVENT
In total, 16 participants reported self-harm or attempted self-harm; 11 (4.5%) were in the FB group and 5 (1.8%) were in the SC group. In the FB group, 9 participants (3.7%) reported a history of self-harm before baseline, and 2 participants (0.8%) reported a new incident self-harm event after baseline. No new incident self-harm event after baseline was reported in the SC group. No psychiatric hospitalizations occurred. Five participants died in the FB group and 1 in the SC group. All deaths were unrelated to study procedures, and no deaths by suicide were recorded or suspected (eTable 3 in 