2.5. Sample Size
SECONDARY
This study is a secondary analysis of aggregated data from two studies in which the sample size was already calculated and in which randomisation was conducted. The data of the present study are the result of merging these two previous studies, in which only participants with SMC have been selected. Both studies were approved by the Clinical Trials Ethics Committee of Aragon (CEICA) and registered in the clinical trials (see Ethical Considerations section). All patients in both studies signed an informed consent form and were given an information sheet.The sample size for the study by Calatayud et al. (2020) [