Statistical analyses
Continuous variables were presented with summary statistics and categorical variables in frequency tables. Time‐to‐event variables were calculated using Kaplan–Meier approach. Binomial exact distribution was used to calculate 95% confidence intervals (95%CIs) for categorical variables. Individual PK parameters were tabulated. Statistical analyses were performed using SAS v.9.2, (SAS Institute Inc), and PK non‐compartmental analysis (NCA) was performed using Phoenix WinNonlin v.6.3.