Statistical methods
Data analysis was performed using SPSS Statistics software (SPSS) version 21.0. Statistical analysis was performed using intention-to-treat (ITT) analysis. The Kolmogorov–Smirnov test was used to verify the normal distribution of continuous variables. The mean ± standard deviation (SD) was used to describe the normally distributed data. The median and Inter Quartile Range (IQR) was used to describe the skewed distribution data.Frequency rates and percentages were used to present categorical variables. The comparison between frequencies was performed using the chi-square test (