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In this study, subjects were randomized to either nicotine replacement patches or ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devices. 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 nicotine cartridge was replaced every day. The cartridge was weighed when dispensed and upon return. On days, 1, 5, and 10. subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and not used for the remaining collection period. A new cartridge was inserted at the end of the 4 hour collection period.  A nicotine replacement 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 cartridge was tracked. A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The produt accountability information was not provided for the nicotine replaement patches.    

da.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TEDP07DA10001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.3g2525g12004-06-06
2TEDP07DA10001

2

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001

3

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.1g2525g12020-06-07
4TEDP07DA10001

4

CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1414g22020-06-08
5TEDP07DA10001

5

CRT9955DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-08
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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 actual product containing nicotine. The sponsor represented each cartridge and patch used. The dose was represented as "1" to indicate one cartidge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was reccorded on other days.           

$titleHtml

ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSTXT

ECDOSU

ECDOSFRM

ECROUTE

ECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  10
PUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-01T08:002020-06-01T08:10
2TEDP07EC10001 2

 PATCH 

1
PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE2020-06-012020-06-02
3TEDP07EC10001 3ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-01T12:102020-06-02
4TEDP07EC10001 4ENDS  
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-022020-06-03
5TEDP07EC100015PATCH 1
PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE2020-06-022020-06-03
6TEDP07EC100016ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC100017PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC10001 8ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-042020-06-05
8TEDP07EC10001 9PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE2020-06-042020-06-05
9TEDP07EC1000110ENDS 10
PUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T8:302020-06-10T8:40
10TEDP07EC1000111 PATCH 1
PATCH PATCH TRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE2020-06-102020-06-11
11TEDP07EC1000112ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T12:402020-06-11
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 Subject 10001 was randomized to the 5%  pharmaceutical strength of the e- nicotine liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The sponsor only represented the active product exposure for each subject in EX. Note, only repreesentive rows are included. 
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ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

EXSTDTC

EXENDTC

1TEDP07EX10001 1e nicotine liquid 1.7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T08:002020-06-01T:8:10
2TEDP07EX10001 2e nicotine liquid 15.1gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T12:102020-06-02
3TEDP07EX10001 3e nicotine liquid 13gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-022020-06-03
4TEDP07EX100014e nicotine liquid 12gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-032020-06-04
5TEDP07EX10001 5e nicotine liquid 9gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-042020-06-05
6TEDP07EX100016e nicotine liquid 7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-10T08:302020-06-10T08:40
7TEDP07EX100017e nicotine liquid 5gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-10T12:402020-06-11
8TEDP07EX20001 1

nicotine replacement therapy

1PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE14mg2020-06-012020-06-02
9TEDP07EX200012nicotine replacement therapy1PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE14mg2020-06-022020-06-03
10TEDP07EX200013nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE14mg2020-06-032020-06-04
11TEDP07EX20001 4nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH PATCHTRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE14mg2020-06-102020-06-11
$warningHtml


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