Statistical analysis of the data
SECONDARY
All efficacy and safety analyses were based on the intention-to-treat principle, and we analyzed our data using the IBM SPSS software package, version 20.0 (Armonk, NY: IBM Corp.). Statistical analysis was performed for the primary and secondary endpoints separately.We described numerical data as means ± S.D. or median and interquartile range We used Pearson’s chi-square to correlate categorical data and the Mann–Whitney 