 Statistical analysis A desired sample size of 20 patients per group for a total of 40 subjects was determined based on 80 power alpha0.10 pilot study, using a 2-tailed test, to detect an effect size of 0.8 for the primary endpoint measured on a continuous scale, and an absolute difference in prevalence of the primary endpoint of 31 to 34 for the expected prevalence in the control group of 5 and 10 respectively. 