Serious adverse events were defined as events
that were fatal or life-threatening, that resulted
in clinically significant or persistent disability,
that required or prolonged a hospitalization, or
that were judged by the investigator to represent
a clinically significant hazard or harm to the
participant that might require medical or surgical
intervention to prevent one of the other
events listed above.30,31 A short list of monitored
conditions were reported as adverse events if
they were evaluated in an emergency department: