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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

Which food can a vegan eat? a. lasagna with cheese b. vegetable risotto c. poached eggs on toast d. chocolate milkshake e. stir-fried chicken

When a researcher debriefs her participants, she: provides a detailed explanation of the study. removes their undergarments. tells them they can stop taking part at any time. provides an detailed explanation of the study, and tells them they can stop taking part at any time.