Statistical analysis
All statistical analyses were completed using SAS 9.4. Quantitative variables were described with number, arithmetic mean, standard deviation (SD), median, Q1, Q3, minimum and maximum. Pharmacokinetic variables were additionally described with coefficient of variation and geometric mean. Count variable was described with frequency and percentage. Unless otherwise stated, all statistical tests were two-sided with α = 0.05, and two-sided 95% confidence intervals were calculated. If the P value was ≥ 0.001, it was rounded to 3 decimal places; if the P value was < 0.001, it was reported as “<0.001”.