TEAEs are presented as N (%) [E] (PP) where N equals the number of subjects to experience that event, (%) equals the percentage of subjects to experience that event, [E] equals the number of events experienced, and (PP) equals the number of events per participant. If a participant has more than one AE coded to the same MedDRA term, the participant is counted only once per treatment, for the AE with least favourable relationship.