2.6 Statistical Analyses
Statistical analyses were performed using SAS® version
9.3 (Cary, NC, USA). Demographic data and baseline characteristics were
listed and summarised. Safety data did not undergo formal statistical
analysis. PK parameters were derived from plasma-concentration versus
time data using a non-compartmental analysis in Phoenix WinNonlin
version 7 (Certara Inc., Princeton, NJ, USA). Plasma-concentration
versus time data and PK parameters were listed, and summarised by
treatment, using descriptive statistics. Mean concentrations were
calculated only if at least ⅔ of the individual concentrations were
above the lower limit of quantification (LLOQ). Individual subject and
mean plasma concentrations were displayed graphically. Planned sampling
times were used to summarise plasma-concentration data; actual sampling
times were used in the derivation of PK parameters.