Safety Assessments
ADVERSE EVENTS, ADVERSE EVENT
Safety and tolerability of elamipretide at a dose of 40 mg/d SC were assessed through recording of adverse events (AEs), ascertained through self-report, vital signs, physical examination, ECGs, and clinical laboratory evaluations. Adverse events were assessed for severity and relationship to study medication throughout the 24-week study. Safety measures were assessed during screening, baseline and weeks 4, 12, and 24.