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The trial randomized 458 people who smoked daily and wanted to quit to receive either a nicotine-containing e-cigarette and placebo tablets, varenicline and an e-cigarette without nicotine, or a placebo tablet and a nicotine-free e-cigarette for 12 weeks

This directive takes into account the WHO Framework Convention on Tobacco Control FCTC (described below) and adds several rules on the sale of tobacco products and electronic cigarettes to the previous directive, adopted in 2001

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