Statistical analysis
REGRESSION
Safety population was defined as every subject randomized and treated at least once with either placebo or drug. All statistical analysis were performed using SASAll OCS-05 concentrations and derived PK data were listed and individual and mean (arithmetic and geometric) concentration time data were plotted. Dose proportionality was assessed by performing a regression analysis of the log transformed CFor the Steady State analysis, for each dose level, log transformed trough concentration levels at pre dose each day (Day 2 through to Day 5) were subjected to a mixed-effects analysis of variance (ANOVA), with study day as a fixed effect and subject as a random effect, in order to establish whether and when steady state had been attained for each dose level. Back transformed ratios for the comparisons of each consecutive day (i.e., Day 3/Day 2) were presented along with corresponding 90% CI.For the accumulation analysis, following logarithmic transformation, Cmax and AUC0-tau values were subjected to a mixed effects ANOVA for each dose level, including a fixed effect of study day and random effect of subject. The analysis included only subjects who had available data for both days within a treatment. Point estimates and 90% CI were constructed for the contrasts between Day 5 and Day 1 using the residual mean square error obtained from the ANOVA. The point and interval estimates were then back-transformed to give estimates of the ratios of the geometric LSMeans and corresponding 90% CI and the p-value for the test of the null hypothesis of non-equivalence. In addition, estimated geometric means were produced for each study day.