Data and Statistical analysis
Statistical analyses were reported using summary tables, graphs, and data listings. Continuous variables were summarized using the N, mean, SD, median, minimum, and maximum. Summaries of PK parameters also included the geometric mean and the coefficient of variation. Categorical variables were summarized by counts and by percentage of subjects in corresponding categories. All raw data obtained from the electronic case report form (eCRF), as well as any derived data, were included in data listings.