"you are called for a man who is not acting right. his wife says he was outside working in the garden but didn't come in for lunch when he was called. she went to check on him and found him sitting next to a stump, confused. you assessment shows a pulse rate of 58, blood pressure of 186/82, respirations of 16, and one of his pupils is dilated. you are unable to detect any signs of trauma and you don't see any obvious indication that he has fallen. you should suspect a(n): "

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