2.3.4. Assessment of Safety and Tolerability
ADVERSE EVENTS, EVENT, ADVERSE EVENT
Safety and tolerability were evaluated via a continuous monitoring during the study, to detect any adverse event, clinical safety, laboratory findings, vital sign measurements, and physical examinations. A blinded, independent expert clinical event committee was appointed by the principal investigator to categorize the adverse events that could possibly be experienced during the trial as not related, unlikely related, possibly related, probably related, or definitely related to the tested treatment [