scenario: you are an athletic trainer working at a rugby match. you witness a two player collision. player 1 comes out of the collision stumbling and looks like he is about to fall over. player 2 gets up and runs back onto the field and continues play. you arrive at player 1 and the player does not respond to any verbal questions you are asking. his eyes are shut, and he does not look like he is breathing.

Adouble-blinded trial for a new indication is conducted under an ind comparing two (2) marketed drugs, at twice the approved prescribed doses. on day 2, subject 603 had difficulty breathing. although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. on day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. these episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. the investigator would submit an sae report for