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Incidence of AEs.
| Variable | No. of patients (%) SS: n=197 |
|---|---|
| Total AEs | 44 (22.3) |
| Study product-related AEs | 6 (3.1) |
| Severe AEs | 2 (1.0) |
| AEs leading to discontinuation | 3 (1.5) |
| Study product-related AEs by type | |
| Amaurosis | 1 (0.5) |
| Dizziness | 3 (1.5) |
| Headache | 1 (0.5) |
| Hypotension | 1 (0.5) |
| Pruritis | 1 (0.5) |
| Mucosal and skin rash | 1 (0.5) |
| Rash | 1 (0.5) |
SS, safety set; AE, adverse effect.
