Statistical analysis
Statistical analysis was carried out using SPSS Release 23.0 software (SPSS Inc., Chicago, IL, USA). The Kolmogorov–Smirnov test was applied to assess the normality of quantitative variables distribution. Frequency (percentage) was presented for categorical data and mean (SD) for normally distributed numerical variables. Data analysis was conducted based on both per-protocol and intention-to-treat (ITT) approaches (