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Several examples are provided below to illustrate the different ways the subjects's history of recreational product usage may be collected in studies.
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This example collects data on all types of recreational products previosuly used by subjectsthe subject. The sponsor only collected the general type of product used. The actual dates of usage were also not collected. The subject provided the duration of use. Usage of these recreational products are represented in the SU domain.
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In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sposnor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.
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This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit. This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.
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