2.7 | Statistical analysis
Data were expressed as mean ± SD for normally distributed variables or
as median [IQR] for skewed variables. The differences between groups
were assessed by using independent Student´s t test (for normally
distributed variables) or Mann-Whitney test (for skewed variables).
Percentages were used to summarize the categorical variables. Pearsonx2 test was used to analyze the differences
between groups for categorical variables. As a non-inferiority trial,
all analyses were performed by per-protocol sets. The significant level
was set at P <0.05. All analyses were performed by using
statistical program IBM SPSS software (Version 25.0).