2.3. Safety
ADVERSE EVENT, SIDE EFFECT
The frequency of spontaneously reported side effects and their severity were assessed. Severity was determined based on reported utilization of medical services in response to the side effects according to the following grading schema based on the Common Terminology Criteria for Adverse Events (CTCAE; v5.0 USDHHS): mild: no intervention (medication or medical advice) needed; moderate: a medication was taken due to the side effect or a participant sought medical advice from their HCP, urgent clinic or ED; severe: the side effect was medically significant but not life-threatening and/or the participant was admitted to the hospital for care and attention; life threatening: immediate medical intervention required and the participant was hospitalized, placed in the intensive care unit due the side effect, and/or suffered long-lasting negative effects as a result of the side effect.