Safety through the assessment of adverse events.Security will be assessed by recording all adverse events; according to the Common Terminology Criteria for Adverse Events version 5.0; based on duration; intensity and possible association with the treatment under study. In particular; the absolute number of unexpected and suspected severe adverse events and serious adverse events recorded during the follow-up study that should not exceed 10%; will be taken into account.

Safety through the assessment of adverse events.Security will be assessed by recording all adverse events; according to the Common Terminology Criteria for Adverse Events version 5.0; based on duration; intensity and possible association with the treatment under study. In particular; the absolute number of unexpected and suspected severe adverse events and serious adverse events recorded during the follow-up study that should not exceed 10%; will be taken into account.