Safety outcomes.
| AE Parameter | Events, n (%) |
| Total AEs | 553 |
| Total No. of patients with ≥1 AE | 119 (53.1) |
| AE severity | |
| Mild | 312 (56.3) |
| Moderate | 170 (30.7) |
| Severe | 71 (12.8) |
| AE relatedness | |
| Related | 6 (1.1) |
| Unrelated | 547 (98.7) |
| Description of AE | Severity | Action Taken |
| Pain from screws | Moderate | No action taken |
| Increase in diarrhea | Moderate | Temporarily discontinued use of device |
| Postoperative ankle dorsiflexion weakness | Moderate | Ongoing |
| Increased pain when wearing device | Mild | Ongoing |
| Mild low back pain with device use | Mild | Resolved |
| Increased back pain with some radicular pain through hips and groin | Severe | Resolved |
Abbreviation: AE, adverse event.