Statistical analysis
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The trial was designed on the assumption of the superiority principle to have 80% power with a The trial team had full access to the data and was responsible for the analysis. All analyses were performed in a blinded manner so that investigators could not know if subjects were assigned to the control or treatment group.Statistical analyses were performed on Stata 15.1® (College Station, Tx). Categorical variables are presented as frequencies and percentages. The normality of continuous variables was examined by the Shapiro–Wilk test. Afterward, they are presented as mean and standard deviation or median and interquartile rank.Categorical variables were compared with ChiInterim analyses were planned at enrollment of 50, 100, 200, and 300 patients, with predefined termination criteria for futility or effectivity [