Abstract:Background FDA is considering to establish a product standard to reduce nicotine in cigarettes to make them “minimally addictive or nonaddictive.” FDA has funded many clinical studies where smokers are switched to smoking low nicotine cigarettes to determine a nicotine ceiling that is appropriate for the protection of the public health. Unlike typical clinical trials involving pharmaceuticals or medical devices, ambulatory studies with low nicotine cigarettes face a unique challenge in that conventional nicoti… Show more
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