Study 3: the exploratory clinical study

GG Giovanni de Girolamo
OA Ole A. Andreassen
MB Michael Bauer
PB Paolo Brambilla
SC Stefano Calza
NC Nicholas Citerà
RC Rosa Corcoy
AF Andrea Fagiolini
MG Miguel Garcia-Argibay
OG Ophélia Godin
FK Florian Klingler
NK Nene F. Kobayashi
HL Henrik Larsson
ML Marion Leboyer
SM Silke Matura
AM Alessandra Martinelli
VP Víctor De la Peña-Arteaga
RP Roberto Poli
AR Andreas Reif
PR Philipp Ritter
LR Linn N. Rødevand
MM Marta Magno
EC Elisa Caselani
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We estimated the sample size based on planned comparisons for 15 variables of interest (Table 6) 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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