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  #1

1. Serious, possible fatal, adverse effects of a new drug may first appear only after the drug is approved for marketing by FDA. The failure to detect these effects is best explained by the use of which of the following in the premarketing clinical trial?


A. Healthy rather than ill subjects
B. Lower doses of the drug than are approved for marketing
C. Pts with positive outcomes only
D. Placebos
E. Too few subjects to detect rare events

  #2

E. Too few subjects to detect rare events

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