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Although the crossover study design in Cohort 2 allows for detection of within-subject drug effects, Cohort 2 was not powered to observe a significant drug x diagnosis interaction

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The authors hypothesized that oxidative degradation of nicotine during the manufacturing of the ingredient or of the final liquids, interactions with packaging material, inadequate handling and storage, or an unstable formulation could have resulted in the high amounts of nicotine-related impurities measured

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