Mike wants to improve his endurance because he wants to try out for the cross country running team in the fall. he works out at the local gym a few days each week and does a variety of activities, but he still feels like his cardiovascular fitness needs improvement. what would be the best thing for mike to do next?

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