Statistical analysis
Patient characteristics at baseline were compared
between the two treatment groups by using Student’s
t-test assuming equal variance and two-tailed distribution
for normally distributed data and Mann–Whitney U-test
for non-normally distributed data of continuous variables,
and by using Fisher0
s exact test was for categorical
variables. The statistical significance of outcomes
between the two treatment groups was analysed by Fisher0
s exact test. P-value less than 0.05 was considered statistically
significant.