We estimated the sample size based on planned comparisons for 15 variables of interest (Table ) for a two independent groups design (MetS + vs MetS−) assuming an expected proportion of Mets (at least three criteria out of five) of approximately 31%. With the estimated cohort of 400 subjects (180 Mets + , 220 Mets−), assuming a power of at least 80% and a significance level of 0.002 (to account for test multiplicity), we are going to be able to identify, at baseline, a significant effect size (ES) of 0.4 for independent t-tests (continuous variables) or an ES of 0.395 for a comparison of two independent proportions (assuming normal asymptotic test).
List of variables to be used for power calculation in the ECS at baseline
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