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Observations about tobacco products and study subjects generated to support a submission are represented in a series of datasets aligned with logical groupings of data per domains. Domains described in this guide are generally aligned with implementation of a single dataset file in which to represent data in scope for a domain.All datasets are structured as flat files with rows representing observations and columns representing variables.In some cases, a dataset implemented for a domain may be split into physically separate datasets to support submission when needed and as allowable by the regulatory authority. 

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