Data are number (%) of patients with at least one adverse event. The safety population consisted of all participants randomly assigned to treatment groups and treated. MedDRA version 14.0 was used for
*p-value from a comparison of the three treatment groups using Fisher's exact test. % refers to the proportion of children who reported an adverse event on any occasion after drug administration.
Most common adverse events overall (regardless of causality) occurring in at least two patients in either treatment group (intention-to-treat/safety population).
