The Sponsor must notify the appropriate bodies (Ethic Committees and Competent Authority CA) of the end of the study. A Close-Out Visit (COV) is the last monitoring visit performed to each involved center, that determines the closure of the trial activities. COVs will be conducted at participating sites once all participants have completed the study, including long-term follow-up, all data queries are resolved, and the Principal Investigator has provided all required documents to complete the Investigator Site File. COV must be performed in each opened site, even if no participants were recruited at site.
