Safety
vomiting, pain, dizziness, headache, nausea, vomiting
EVENTS
During the trial, 40 episodes of AEs were recorded: 13 in group 1 and 27 in group 2. The AEs were mild (72.5%) or moderate (27.5%) in intensity, probably to possibly related to treatment, and all of them had complete resolution. The main AEs were nausea/feeling sick: 38.5% of group 1 and 40.7% of group 2; epigastric pain: none in group 1 and 22.2% of group 2; and vomiting: 15.4% of group 1 and 11.1% of group 2. Three participants from group 1 and 8 from group 2 were excluded from the study because of AEs; these events included nausea, vomiting, epigastric pain, dizziness, headache, and malaise.