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Incidence of adverse events during the trial
| Episodes | Participants | |
|---|---|---|
| n | n (%) | |
| AE information | ||
| Total AEs | 51 | 12 (100) |
| Treatment-related AEs | 21 | 9 (75) |
| Total SAEs | 1 | 1 (8) |
| Treatment-related SAEs | 0 | 0 (0) |
| AEs leading to withdrawal | 0 | 0 (0) |
| Deaths | 0 | 0 (0) |
| AEs by study phase | ||
| Surgical | 10 | 7 (58) |
| Rehab-only | 4 | 4 (33) |
| Programming | 12 | 7 (58) |
| DBS + rehab | 7 | 5 (42) |
| Rehab carryover | 5 | 5 (42) |
| Explant | 4 | 3 (25) |
| Long-term follow-up | 9 | 7 (58) |
AE, adverse event; SAE, serious adverse event; rehab, rehabilitation.
