Gli eventi avversi e/o i risultati di analisi anomali che il protocollo reputa essenziali ai fini della sicurezza sono notificati al comitato etico e allo sponsor.
Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.
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Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol. 