Statistics, pharmacokinetic and pharmacokinetic/pharmacodynamic analysis.
Outcomes were summarized for each treatment group and for the entire population using descriptive statistics. Formal sample size calculations were not performed in either study. Pharmacokinetic parameters were analyzed by noncompartmental methods using Phoenix WinNonlin (Pharsight Corporation, version 6.4) and SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). A power model was used to characterize dose proportionality of the log-transformed pharmacokinetic parameters in the single ascending dose range from 30 to 480 mg. EBA was calculated (see equation below) as the slope of the change from baseline (i.e., the mean of the values from day 2 and day 1 when both values were present; if only one value was present, it was used as baseline) to the end of the 14-day treatment from baseline in log