Safety
DBS-EARLY
ADVERSE EVENTS
Within the first 6 months, a total of 38 adverse events (AEs) occurred in 6 patients, including 24 AEs and 7 serious adverse events (SAEs) in 4 patients in the DBS-EARLY ON group and 14 AEs and 7 SAEs in 2 patients in the DBS-LATE ON group. During the following 12 months, a total of 82 AEs were recorded in 9 patients. Of all of the AEs, 68.9% were rated as mild to moderate. SAEs were mostly related to alcohol relapse and re-admission for detoxification, as any case of inpatient treatment had to be considered by law as SAE. Six AEs were related to a surgical procedure (DBS-EARLY ON: 