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The examples in this section illustrate various methods for displaying study product exposure data, as well as data that may be collected on the use of other nicotine sources. These examples are provided to illustrate specific exposure based on how it was measured (e.g., by volume, by weight, number of product consumed).

Example

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SDTM Example. Study Product Exposure and Other Recreational Drug Use
SDTM Example. Study Product Exposure and Other Recreational Drug Use

In this example, the EC domain is not used by the applicant to represent collected exposure. Exposure is represented based on the volume of the e-nicotine liquid cartridges. 

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Example

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SDTM Example. Nicotine Exposure ENDS
SDTM Example. Nicotine Exposure ENDS

In this example, both the EC and EX domains are used. Exposure is based on the weight of the e-nicotine liquid cartridges. 

Example

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SDTM Example.Nicotine Exposure Double-Dummy Design
SDTM Example.Nicotine Exposure Double-Dummy Design

In this example, subjects were exposed to multiple study products. The actual dates and times of use for each product are represented. 

Example

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SDTM Example.Nicotine Exposure Crossover Design
SDTM Example.Nicotine Exposure Crossover Design

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