Statistical analysis
The full analysis set (FAS) included all participants who received the study drug at least once, with at least one efficacy evaluation available. The safety set (SS) included participants who received the study drug at least once, with safety assessments available after receiving the study drug.Statistical analysis was performed with SPSS 19.0 (IBM, Armonk, NY, USA). Continuous data were presented as means ± standard deviations or medians (minimum, maximum) according to the distribution (normal or not). Categorical data were presented as 