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In this study, subjects were randomized to either nicotine replacement patches or ENDs device which used e nicotine liquid. 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 weighed when dispensed 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 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

CRT8755RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001

3

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

4

CRT9757RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g14143g22020-06-08
5TEDP07DA10001

5

CRT8755DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-09
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EC was used to represent the collected exposure data since a double dummy design was used.,while the EX domain was used to represent the subject's exposure to the actual product containing nicotine. The sponsor represented each cartridge used. The dose was represented has "1" to indicate only one cartidge or patch wsa used. The actual date and time of usage of the cartridge was recorded precisely on days 1, 5, and 10, while only the date of usage was reccorded on other days.           

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ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSU

ECROUTE

ECFREQECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  1CARTRIDGEINHALED



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

 PATCH 

1PATCHTRANSDERMAL
ARMRIGHTUPPERPRODUCT EXPOSURE2020-06-012020-06-02
3TEDP07EC10001 3ENDS 1CARTRIDGEINHALEDAD LIBITUM


PRODUCT EXPOSURE2020-06-01T12:102020-06-02
4TEDP07EC10001 1ENDS  1CARTRIDGEINHALEDAD LIBITUM


PRODUCT EXPOSURE2020-06-022020-06-02
5TEDP07EC100011PATCH 1PATCHTRANSDERMAL
ARMLEFTUPPERPRODUCT EXPOSURE2020-06-022020-06-03
6TEDP07EC100012ENDS 1CARTRIDGEINHALEDAD LIBITUM


PRODUCT EXPOSURE2020-06-032020-06-03
7TEDP07EC100013PATCH 1PATCHTRANSDERMAL
LEGLEFTUPPERPRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC10001 4ENDS 1CARTRIDGEINHALEDAD LIBITUM


PRODUCT EXPOSURE2020-06-042020-06-05
8TEDP07EC10001 5PATCH 1PATCHTRANSDERMAL
LEGLEFTLOWERPRODUCT EXPOSURE2020-06-042020-06-05
9TEDP07EC100016ENDS 1CARTRIDGEINHALEDONCE


PRODUCT EXPOSURE2020-06-09T8:302020-06-09T8:40
10TEDP07EC100017 PATCH 1PATCH TRANSDERMAL
LEGRIGHTLOWERPRODUCT EXPOSURE2020-06-102020-06-11
11TEDP07EC100018ENDS 1CARTRIDGEINHALEDAD LIBITUM


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 active nicotine patch with a pharmaceutical strength of 14mg. The sponsor only represented the active product exposure for each subject in EX. .   
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ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXROUTE

EXFREQEXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

ECSTDTC

ECENDTC

1TEDP07EX10001 1e nicotine liquid 3gINHALEDONCE


PRODUCT EXPOSURE5%2020-06-01T08:002020-06-01T:8:10
2TEDP07EX10001 2e nicotine liquid 15gINHALEDAD LIBITUM


PRODUCT EXPOSURE5%2020-06-01T08:102020-06-02
3TEDP07EX10001 3e nicotine liquid 13gINHALEDAD LIBITUM


PRODUCT EXPOSURE5%2020-06-022020-06-02
4TEDP07EX100014e nicotine liquid 12gINHALEDAD LIBITUM


PRODUCT EXPOSURE5%2020-06-032020-06-03
5TEDP07EX10001 5e nicotine liquid 9gINHALEDAD LIBITUM


PRODUCT EXPOSURE5%2020-06-042020-06-05
6TEDP07EX100016e nicotine liquid 7gINHALEDONCE


PRODUCT EXPOSURE5%2020-06-09T08:302020-06-09T08:40
7TEDP07EX100017e nicotine liquid 5mgINHALEDAD LIBITUM


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

nicotine replacement therapy

1PATCHTRANSDERMALQDARMRIGHTUPPERPRODUCT EXPOSURE14mg2020-06-012020-06-02
9TEDP07EX200012nicotine replacement therapy1PATCHTRANSDERMALQDARMLEFTUPPERPRODUCT EXPOSURE14mg2020-06-022020-06-03
10TEDP07EX200013nicotine replacement therapy1PATCHTRANSDERMALQDLEGLEFTUPPERPRODUCT EXPOSURE14mg2020-06-032020-06-04
11TEDP07EX20001 4nicotine replacement therapy1PATCHTRANSDERMALQDLEGLEFTLOWERPRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH TRANSDERMALQDLEGRIGHTLOWERPRODUCT EXPOSURE14mg2020-06-102020-06-11
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