Statistical analysis
The per-protocol or PP analysis set was used for statistical analysis using the SPSS version 25.0 (SPSS, Chicago, Illinois, USA). The PP set includes all subjects, who have complete data on the primary effectiveness parameter during 12 weeks follow-up. All continuous variables were expressed as mean±SD (standard deviation) and compared using the t-test for normally distributed data or Mann-Whitney U test for distribution-free data. All qualitative variables were expressed as proportions/percentages, and compared using Chi-squared test or Fisher's Exact test. A p value of < 0.05 was considered statistically significant.