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For example, the Draft Guidance provides no information on the FDAs criteria for the following in relation to a trial: The required effect size and acceptable statistical significance The comparator products (is it any tobacco-flavored product or the manufacturers?) The preferred trial duration and follow-up The acceptable end-points (which definition of smoking cessation, what weight is placed on cutting down or migration from exclusive smoking to dual use?) The selection criteria for the study population (are they people wanting to quit or people who smoke?) The handling of non-compliance (in the highly likely event that people assigned to either the control or experimental trial arms use flavors other than those assigned to them) Though longitudinal cohort studies are mentioned, these are only possible with products already on the market, so this will, at best, serve as a legacy method and can only support pre-market applications if studies conducted outside the United States can be used

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Reached Thursday by The Canadian Press, a spokesperson for Rothmans Benson & Hedges said the Markham, Ont.-based company would not provide any comment about the product, how long it will be on the market or the criticism levelled over its packaging