2.5. Statistical analysis
We estimated that a minimum sample of 56 patients would be needed, where the threshold response, Since the use of statistical tests in the absence of reliable sample size calculation decreases its weightage, we calculated our final sample size considering an expected dropout rate of 0.05 based on our pilot study. Hence, if a dropout rate (R) is expected, a simple but adequate adjustment is provided by NFor statistical testing, the Chi-square test of independence was used to test the relationship between 2 categorical variables, and the Mann–Whitney 