| Treatment group (n = 50) | Control group (n = 45) | P value |
---|---|---|---|
Did the subject have at least one SAE within 1- month of enrollment? | Â | Â | 0.0568* |
Yes | 24 (48.0%) | 13 (28.9%) | Â |
No | 26 (52.0%) | 32 (71.1%) | Â |
Did the subject have at least one SAE within 3- months of enrollment? | Â | Â | 0.048* |
Yes | 29 (58.0%) | 17 (37.8%) | Â |
No | 21 (42.0%) | 28 (62.2%) | Â |
Did the subject have at least one SAE within 12- months of enrollment? | Â | Â | 0.143* |
Yes | 34 (68.0%) | 24 (53.3%) | Â |
No | 16 (32.0%) | 21 (46.7%) | Â |
SAE: Serious adverse event *Chi-Square p value. |  |  |  |