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However, an American Thoracic Society (ATS) systematic review of eight studies demonstrated that extended use of a controller therapy for greater than 12 weeks leads to significantly higher sustained quit rates and lower relapse rates compared with standard use of six to 12 weeks, with a number needed to treat (NNT) of 19 for one additional patient achieving abstinence at one year

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FDA Importantly, due to a recent decision by the United States District Court for the District of Columbia, the warnings set forth in 21 C.F.R