Data and Statistical Analysis
All statistical analyses were performed using SAS GRID Linux/SAS Studio
(Version 9.4, or higher). PK parameters for elamipretide and its
metabolites, M1 and M2, were summarized using descriptive statistics.
Comparisons between treatments (elamipretide with each separate
intervention versus elamipretide alone) were evaluated by an analysis of
the log-transformed PK parameters (Cmax and
AUC0-6h) by performing an analysis of variance with
treatment effects. From these analyses, least square means (LSMs), least
square treatment differences, and 90% confidence intervals (CIs) for
the treatment differences on log-scale were obtained. The results were
transformed back to the original scale by exponentiation to provide
treatment geometric LSM, point estimates of the geometric test
(elamipretide alone)/reference (elamipretide with each separate
intervention) LSM ratios, 90% CI, for these ratios, and p-values.
Chi-square test or Fisher exact test were used to examine the
differences in ISR responses between treatment arms at each timepoint.
The data and statistical analysis comply with the recommendations on
experimental design and analysis in pharmacology. The thresholds for
statistical significance and trends toward significance were defined as
p<0.05 and p<0.20, respectively.