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

The example below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources.   

In the following example, the sponsor reported protocol described usage of a nicotine inhaler using the EX and EC domains. Usage of non-protocol defined product usage (alcohol and other tobacco products) during the study were represented in the SU domain. Additionally, any usage of nicotine patches to reduce dependency on tobacco were reported in the CM domain. Study product exposure was represented as the number of cartridges used. The pharmaceutical strength of each cartridge was represented. 

Example

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

In this example, the EC domain is not used by the sposnor applicant to represent collected exposure. Expoure was 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 was is based on the weight of the e-nicotine liquid cartridges. 

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

Example

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

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