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.