Statistical analysis
Statistical analysis was conducted using SAS statistical software for Windows, Release V.9.4 (Armonk, NY, USA). Phoenix WinNonlin version 7.0 (Certara, Princeton, NJ, USA) was used for statistical analysis of the pharmacokinetic parameters. Descriptive statistics were presented using the mean and standard deviation, median, and interquartile range. An Analysis of Covariance (ANCOVA) model was used to calculate the least square mean (LSmean), the LSmean difference and the 95% confidence interval (95% CI) of efficacy outcomes between groups and time points with Tukey’s multiplicity correction. A Model check was performed to assess on statistically significant indicators, and the Kruskal–Walis test was used for indicators that did not meet the assumptions of normality and homogeneity of variance to further confirm the statistical differences. The Wilson score method was used to calculate 95% CI and the Newcombe–Wilson Score method was used for calculating confidence intervals of the difference in the proportion of patients achieving ≥ 30% reduction in liver biochemical parameters and LFC from baseline between two groups. All the statistical tests were two-sided, and a 5% type I error was used to reject null hypotheses.