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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 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 tracked.  A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of the cartridge each day.  Each cartridge had a uniquely assigned number. The sponsor used DAREFID that appeared on the label to identify the cartridge

da.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUDASTATDAREASNDVISITNUMDADTC
1ABCDAABC-01001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25g2525g

12004-06-26
2ABCDAABC-01001

2

CRT8768DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25g2525g

12004-06-26
3ABCDAABC-01001

3

CRT8769DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25g2525g

12004-06-26
4ABCDAABC-01001

4

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID




NOT DONESubject forgot to return the cartridge
2020-07-06
5ABCDAABC-01001

5

CRT8768RETAMTReturned AmountSTUDY PRODUCTE-LIQUID24g2424g

22020-07-06
6ABCDAABC-01001

6

CRT8769RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1010g

22020-07-06
7ABCDAABC-01001

7

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25g2525g

22020-07-06
8ABCDAABC-01001

8

CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID14g14143g

32020-07-10
9ABCDAABC-01001

9

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1010g

32020-07-10
10ABCDAABC-01001

10



Dispensed AmountSTUDY PRODUCTPAtCH7







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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 product containing nicotine.    

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ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSU

ECROUTE

ECFREQECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  1CONTAINERINHALEDONCE


TREATMENT2020-06-01T8:002020-06-01T:8:10
2TEDP07EC10001 2

 PATCH 

1PATCHTRANSDERMAL
ARMRIGHTUPPERTREATMENT2020-06-012020-06-02
3TEDP07EC10001 3ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-01:T12:102020-06-02
4TEDP07EC10001 1ENDS  1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-022020-06-02
5TEDP07EC100011PATCH 1PATCHTRANSDERMAL
ARMLEFTUPPERTREATMENT2020-06-022020-06-03
6TEDP07EC100012ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-032020-06-03
7TEDP07EC100013PATCH 1PATCHTRANSDERMAL
LEGLEFTUPPERTREATMENT2020-06-032020-06-04
7TEDP07EC10001 4ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-042020-06-05
8TEDP07EC10001 5PATCH 1PATCHTRANSDERMAL
LEGLEFTLOWERTREATMENT2020-06-042020-06-05
9TEDP07EC100016ENDS 1CONTAINERINHALEDONCE


TREATMENT2020-06-T09;8:302020-06-T09;8:40
10TEDP07EC100017 PATCH 1PATCH TRANSDERMAL
LEGRIGHTLOWERTREATMENT2020-06-102020-06-11
11TEDP07EC100018ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-10:T12:402020-06-11
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TIME FORMATS NEED TO BE FIXED 
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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


TREATMENT5%2020-06-01:T8:002020-06-01:8:10
2TEDP07EX10001 2e nicotine liquid 15gINHALEDAD LIBITUM


TRE5ATMENT5%2020-06-01:T8:102020-06-02
3TEDP07EX10001 3e nicotine liquid 13gINHALEDAD LIBITUM


TREATMENT5%2020-06-022020-06-02
4TEDP07EX100014e nicotine liquid 12gINHALEDAD LIBITUM


TREATMENT5%2020-06-032020-06-03
5TEDP07EX10001 5e nicotine liquid 9gINHALEDAD LIBITUM


TREATMENT5%2020-06-042020-06-05
6TEDP07EX100016e nicotine liquid 7gINHALEDONCE


TREATMENT5%2020-06-09T8:302020-06-09T8:40
7TEDP07EX100017e nicotine liquid 5mgINHALEDAD LIBITUM


TREATMENT5%2020-06-10T::2402020-06-11
8TEDP07EX20001 1

nicotine replacement therapy

1PATCHTRANSDERMALQDARMRIGHTUPPERTREATMENT14mg2020-06-012020-06-02
9TEDP07EX200012nicotine replacement therapy1PATCHTRANSDERMALQDARMLEFTUPPERTREATMENT14mg2020-06-022020-06-03
10TEDP07EX200013nicotine replacement therapy1PATCHTRANSDERMALQDLEGLEFTUPPERTREATMENT14mg2020-06-032020-06-04
11TEDP07EX20001 4nicotine replacement therapy1PATCHTRANSDERMALQDLEGLEFTLOWERTREATMENT14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH TRANSDERMALQDLEGRIGHTLOWERTREATMENT14mg2020-06-102020-06-11
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