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In this study, subjects were randomized to either nicotine replacement patches or ENDs device which used e ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devicedevices. 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 nicotine cartridge was replaced every day. The cartridge was weight weighed when dispended 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 device was inserted and then used for 10 puffs were taken over 10 minutes, and then not used for 4 hoursthe remaining collection period. A new cartridge was insert inserted at the end of the 4 hours. The  -hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.     

...

In this study, the weight of the contents in the cartridges were cartridge was tracked.   A Product Accountability (The DA ) domain was submitted used to represent dispensed and returned weights of each cartridge.   Only a few rows are shown. The produt accountability product accountability information was not provided for the nicotine replaement patches replacement patches.    

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TEDP07DA10001 10001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.3g2525g12004-06-06
2TEDP07DA10001 10001

2

CRT8755CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001 10001

3

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.1g2525g12020-06-07
4TEDP07DA10001 10001

4

CRT9757CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1414314g22020-06-08
5TEDP07DA10001 10001

5

CRT8755CRT9955DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-0908

EC was used to represent the collected exposure data since a double dummy -blind design was used. ,while the  The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The sponsor applicant represented each cartridge and patch used. The dose was represented has as "1" to indicate only one cartidge wsa used1 cartridge or patch. The actual  actual date and specific time of usage of the cartridge was recorded precisely on days 1, 5, and 10, while only the date of usage was reccorded recorded on other days.           

Dataset wrap
Nameec
Dataset2

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSTXT

ECDOSU

ECDOSFRM

ECROUTE

ECFREQ

ECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  
1
10
PUFFCARTRIDGE
INHALED
RESPIRATORY (INHALATION)


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

 PATCH 

1
PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE2020-06-012020-06-02
3TEDP07EC10001 3ENDS 
AD LIBITUM
1
PUFFCARTRIDGE
INHALEDAD LIBITUM
RESPIRATORY (INHALATION)


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

AD LIBITUMPUFFCARTRIDGE
INHALEDAD LIBITUM
RESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-022020-06-
02
03
5TEDP07EC10001
1
5PATCH 1
PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE2020-06-022020-06-03
6TEDP07EC10001
2
6ENDS 
1

AD LIBITUMPUFFCARTRIDGE
INHALEDAD LIBITUM
RESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-032020-06-
03
04
7TEDP07EC10001
3
7PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC10001 
4
8ENDS 
1

AD LIBITUMPUFFCARTRIDGE
INHALEDAD LIBITUM
RESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-042020-06-05
8TEDP07EC10001 
5
9PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE2020-06-042020-06-05
9TEDP07EC10001
6
10ENDS 10
1

PUFFCARTRIDGE
INHALEDONCE
RESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-
09T8
10T8:302020-06-
09T8
10T8:40
10TEDP07EC10001
7
11 PATCH 1
PATCH PATCH TRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE2020-06-102020-06-11
11TEDP07EC10001
8
12ENDS 
1

AD LIBITUMPUFFCARTRIDGE
INHALEDAD LIBITUM
RESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T12:402020-06-11

 Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e-liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The applicant only represented the active product exposure for each subject in EX.

TREATMENT
Dataset wrap
Nameex
Dataset2

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXFREQ
EXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

ECSTDTC

EXSTDTC

ECENDTC

EXENDTC

1TEDP07EX10001 1e nicotine liquid 
3
1.7g
INHALEDONCE
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T08:002020-06-01T:8:10
2TEDP07EX10001 2e nicotine liquid 15.1g
INHALEDAD LIBITUMTRE5ATMENT
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-
01T08
01T12:102020-06-02
3TEDP07EX10001 3e nicotine liquid 13g
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
5%2020-06-022020-06-
02
03
4TEDP07EX100014e nicotine liquid 12g
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
5%2020-06-032020-06-
03
04
5TEDP07EX10001 5e nicotine liquid 9g
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
5%2020-06-042020-06-05
6TEDP07EX100016e nicotine liquid 7g
INHALEDONCE
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
5%2020-06-
09T08
10T08:302020-06-
09T08
10T08:40
7TEDP07EX100017e nicotine liquid 5
mg
g
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
5%2020-06-10T12:402020-06-11
8TEDP07EX20001 1

nicotine replacement therapy

1PATCHPATCHTRANSDERMAL
QD
ARMRIGHTUPPER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-012020-06-02
9TEDP07EX200012nicotine replacement therapy1PATCHPATCHTRANSDERMAL
QD
ARMLEFTUPPER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-022020-06-03
10TEDP07EX200013nicotine replacement therapy1PATCHPATCHTRANSDERMAL
QD
LEGLEFTUPPER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-032020-06-04
11TEDP07EX20001 4nicotine replacement therapy1PATCHPATCHTRANSDERMAL
QD
LEGLEFTLOWER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH PATCHTRANSDERMAL
QD
LEGRIGHTLOWER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-102020-06-11