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Adverse events in the safety set
| Variable | Placebo | HL301 | p value |
|---|---|---|---|
| Number | 85 | 81 | |
| Number of AEs | 4 (4.71) | 1 (1.23) | 0.3681 |
| AEs with possible relation to study drug | 3 (3.53) | 0 | 0.2459 |
| Number of SAEs | 0 | 0 | NA |
| AEs lead to withdrawal of the study drug | 0 | 0 | NA |
Values are presented as number (%).
AE, adverse event; SAE, severe adverse event; NA, not available.
