(See: Brown J, Beard E, Kotz D, Michie S, West R. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction. .)

Now, if those 100 resistant smokers were then followed for six months, we would expect that very few of them would quit smoking because all of them had already tried e-cigarettes and failed.

It is clear, then, that this study violated the principles of informed consent, as subjects did not provide informed consent prior to being enrolled in the research.

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The Rest of the Story

Hopefully, the FDA will not be swayed by this nonsense.

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