Composition of the data monitoring committee, its role and reporting structure {21a}
RECRUITMENT
The data monitoring group is composed by Stefano Nava (lead investigator), Sabino Scolletta (lead investigator), and Salvatore Maurizio Maggiore (lead investigator). The role of the data monitoring committee is to independently review the study protocol, recruitment of patients and liaising with the principal investigator to be involved in the safety monitoring interim analysis, and agreement on the final manuscripts. The Data Quality Assurance group is composed by Eduardo Rocca, Federico Longhini, Gianmaria Cammarota, Giovanni Misseri, and Alberto Dal Molin and will be responsible for monitoring data for inconsistency and missing data.