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The examples 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.  Multiple examples are provided to illustrate specific exposure based on how it was measured (e.g., by volume, by weight or number of product consumed).

In this example, exposure is based on the number of ENDS cartridges used. 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. The pharmaceutical strength of each cartridge was represented. 

Example

Include Page
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 to represent collected exposure. Expoure was represented based on the volume of the e-nicotine liquid cartridges. 

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