Safety
Apart from data relating to ISRs, which were not captured as AEs (designated study endpoints), few TEAEs were reported on daily SC elamipretide 60mg. The only TEAE observed in >one subject was mild somnolence in the diphenhydramine treatment arm (five subjects [50%]). It is reasonable to suspect that night-time diphenhydramine could reduce the occurrence of somnolence, but was not a part of the study protocol; therefore, a conclusion cannot be drawn. There were no apparent differences between treatment arms in vital signs, ECG parameters, or laboratory values.