Table 1.
Reasons for study discontinuation
Reason | PS-DHA | Placebo |
---|---|---|
Protocol violation | 2 | 1 |
Withdrawn consent | 5 | 6 |
Adverse events* | 5 | 5 |
Severe adverse events** | 1# | 1## |
Sum | 13 | 13 |
* Adverse events are specified in Table 6
** Classified by the study physician as not related to the study treatment
# Hospitalization due to hyponatremia
## Hospitalization due to atrial fibrillation and epigastric pain