The sample size was calculated for non-inferiority, based on the new approach being at least as good as the existing one. The effectiveness of Protocol 1 is presumed to be 57%, according to the literature (12), and Protocol 2 is presumed to be least as good as Protocol 1. The difference in effectiveness between the two protocols should be less than or equal to 20%. With a power of 80% and a significance level of 97.5%, a one-tailed test requires a sample size of 97 individuals per arm. Since a maximum of 5% of patients are expected to be lost in the first month post-treatment, a final sample size of 103 individuals per arm was calculated and, therefore, a total of 206 individuals will be randomly assigned. These calculations are performed using the Stata 14© ssi module.