Safety
ADVERSE EVENT
In the safety analysis set of 164 patients, at least 1 adverse event occurred in 21 (48.8%) of 43 high-dose, 21 (52.5%) of 40 intermediate-dose, 20 (48.8%) of 41 low-dose, and 19 (46.3%) of 41 placebo recipients questioned 24 weeks after the first dose (percentage point difference between high dose and placebo = 2.5, 95% CI = −0.19 to 0.24; 