Safety
Apart from data relating to ISRs, which were not captured as AEs because they were the designated study endpoints, few TEAEs were reported in this study on daily SC elamipretide doses of 60 mg. The only TEAE observed in more than one subject was that of somnolence in the diphenhydramine treatment arm, where five subjects (50%) reported mild somnolence. Although it is reasonable to suspect that night-time administration of diphenhydramine could reduce the occurrence of somnolence, doing so was not a part of the study protocol. Therefore, a conclusions cannot be drawn here. There were no apparent differences between any treatment arms with respect to vital signs, ECG parameters, or laboratory values.