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Clinical trials contain five phases (0-4) in order to rigorously evaluate the efficacy and safety of a given drug or medical product.
Which of the following is the BEST description of phase 2?
Studies that occur after the drug has been approved for marketing by the FDA.
Studies that evaluate the efficacy and safety of the drug in various populations and at different dosages.
Exploratory or screening studies with limited drug exposure.
Studies that gather preliminary data on the efficacy of the drug as compared to a placebo or standard therapy in a specific, affected population.
Studies conducted with healthy volunteers to establish drug safety.