Table 2 Criteria used to select AEs for reporting
| Criteria | n (%) |
|---|---|
| Most frequent AEs | 17 (32) |
| All AE’s that occurred | 17 (32) |
| Other | 6 (11) |
| A pre-specified list of AEs | 5 (9.4) |
| Unclear | 3 (5.7) |
| Not applicable as no AE reported | 3 (5.7) |
| Any AE with sig diff between treatment groups | 2 (3.8) |