Example Exposure ENDS 2

In this study, subjects were randomized were randomized to either nicotine replacement patches or ENDs. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS device. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days,  The nicotine patch was applied at  rotating sites, and the ENDS cartridge was replaced every day. The cartridge was weight when dispended and upon return. On days, 1, 5, 10 subjects remained in the clinic for 4 hours for collection of biomarkers.  On these days, a new ENDS cartridge device was inserted and then used for 10 minutes, and then not used for 4 hours. A new cartridge was insert at the end of 4 hours. The  patch was applied prior to using the ENDS device on these days.        

The SU domain was used to represent the number of cigarettes used, but is not shown.  

In this study,  the weight of the contents in the cartridges were being accounted for, as well as the number of patches.  A Product Accountability (DA) domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. The sponsor used DAREFID  that appeared on the label to identify the cartridge.  Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed.  Cartridges were replaced at each visit. DADTC are the visit dates when the cartridge was returned or dispensed.  A returned cartridges that was not used was recorded as having weight of the dispensed cartridges,   

NOTE ;  A REAL EXAMPLE FROM A SPONOSR WOULD BE HELPFUL. THESE ARE MADE UP AMOUNTS. NEED TO ENSURE EXPOSURE NUMBERS MATCH THESE WEIGHTS:  

EC was used to represent the collected exposure data since a double dummy design was used. The EX domain  was used to represent the subject's exposure to the product containing nicotine.