Adverse event reporting and harms {22}
ADVERSE EVENTS, EVENTS, ADVERSE REACTIONS, ADVERSE EVENT
The investigators will be responsible for collecting all the adverse events in the clinical history based on those referred by the patient spontaneously or by interview during the follow-up visits. The causality of the adverse event related to the intervention will be evaluated and recorded in the clinical history and in the eCRF.The investigators will report to the sponsor all serious adverse events occurring to subjects treated in the clinical trial, without undue delay, but not later than within 24 h of obtaining knowledge of the events.The sponsor will report to the Spanish Agency for Medicines and Health Products all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products occurring in this clinical trial.