Participant Disposition
ADVERSE EVENT
Two hundred ninety-six participants were screened, and 218 participants were randomized to treatment. Two participants in the elamipretide group and 1 patient in the placebo group had the treatment withdrawn due to adverse event before study discontinuation. The ITT population included 109 participants in the elamipretide group and 109 participants in the placebo group. The PP population included 102 participants in the elamipretide group and 103 participants in the placebo group. ITT = intention-to-treat; PP = per-protocol.Participant demographics at baseline were similar between treatment groups, and characteristics demonstrated similar impairment in PMM (Baseline Participant DemographicsMost Bothersome Symptom in PMMSA at ScreeningBaseline genetic test results showed most of the participants (74%, n = 162) had mtDNA alteration, with the remainder (26%, n = 56) having nDNA defects (Participants' Genetic Classifications