After a six-week period of controlled trials, the FDA approves a drug that appears safe and effective in the treatment of school-age boys with ADHD. Once it is approved, doctors are permitted to prescribe it for any patients who:
a. match the subjects in the controlled study in regard to gender–in this example, males with a diagnosis of ADHD.
b.match subjects in the controlled study in regard to age–in this example, school age boys and girls.
c. match subjects in the controlled study in regard to ethnicity or cultural background–in this example, Americans.
