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CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting

RAI Services Company · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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nasmokingtobacco-use
This study will be a single-center, controlled, open-label, parallel two-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to one of two different ENDS, Product A with 1.5% nicotine, and Product B with 3.0% nicotine, over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
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