TABLE 3.
Summary of the Adverse Events observed in the trial [SS].
| Treatment group | Control group | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|
| N = 102 | N = 103 | N = 205 | |||||||
| Cases | n | Incidence (%) | Cases | n | Incidence (%) | Cases | n | Incidence (%) | |
| Adverse events | 0 | 0 | 0.0 | 2 | 1 | 1.0 | 2 | 1 | 0.5 |
| Adverse drug reactions | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 |
| Serious Adverse events | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 |