Assessment and reporting of Adverse Events The occurrence of adverse events (AE) and serious adverse events (SAE) will be recorded from the time of consent until discharge. For each AE, the relationship to the study procedures and monitoring, severity, expectedness, outcome will be determined by the PI and recorded in the study source accordingly If the case a subject withdraws from the study due to a serious adverse event the local Institutional Review Board (IRB) will be notified within 10 days.