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This is a study where subjects were randomized to 3 different concentrations of e-nicotine liquid, or their usual brand of cigarettes. The subject used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two weeks, the subjects were confined to the clinical for one day. They were required to not use any tobacco products for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit. If the level, was too high, the visit was re-scheduled. Subjects were instructed to take 10 puffs on the e-cigarette/usual brand of cigarettes in the morning and afternoon. Puff topography was measured in the morning and afternoon using the same device for all subjects. Subjects were not allowed to use any tobacco products between the morning and afternoon sessions.

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Dataset wrap

Name	ex

Dataset2

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	SPTOBID	EXLNKID	EXTRT	EXDOSE	EXDOSTXT	EXDOSU	EXROUTE	EXPSTRG	EXPSTRGU	EXSTDTC	EXENDTC
1	TOPT001	EX	3001	1	EC-333		e-nicotine liquid		AD LIBITUM		INHALED	8	mg/mL	2020-06-26	2020-07-14
2	TENDS01TOPT001	EX	3001	2	EC-333	1	e-nicotine liquid	10		PUFFS	INHALED	8	mg/mL	2020-07-15T9:00	2020-07-15TT9:45
3	TENDS01TOPT001	EX	3001	3	EC-333	2	e-nicotine liquid	10		PUFFS	INHALED	8	mg/mL	2020-07-15T3:00	2020-07-15TT3:45
4	TENDS01TOPT001	EX	4001	1	EC-333		e-nicotine liquid		AD LIBITUM		INHALED	16	mg/mL	2020-09-06	2020-09-22
5	TENDS01TOPT001	EX	4001	2	EC-333	1	e-nicotine liquid	10		PUFFS	INHALED	16	mg/mL	2020-09-22T9:00	2020-09-22T9:30
6	TENDS01TOPT001	EX	4001	3	EC-333	2	e-nicotine liquid	10		PUFFS	INHALED	16	mg/mL	2020-09-22T3:00	2020-09-22T3:30
7	TENDS01TOPT001	EX	5004	1			Cigarettes Brand XYZ		AD LIBITUM		INHALED	12.1	mg/cigarette	2020-10-08	2020-10-22
8	TENDS01TOPT001	EX	5004	2		1	Cigarettes Brand XYZ	10		PUFFS	INHALED	12.1	mg/cigarette	2020-10-22T9:00	2020-09-22T9:30
9	TENDS01TOPT0011	EX	5004	3		2	Cigarettes Brand XYZ	10		PUFFS	INHALED	12.1	mg/cigarette	2020-10-22T3:00	2020-09-22T3:30

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Dataset wrap

Name	faex

Rowcaps

Rows 1, 6:	Show the Number of Puff Puffs taken in the time interval specified in FADTC and FAENDTC. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken.
Rows 2-5:	Show the various measurements recorded for subject 3001 for Puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC provides the timing of each puff. The individual puff data for the afternoon are not shown.
Rows 6-10:	Show the various measurements recorded for subject 3001 for Puff 10 during the afternoon administration of the tobacco product. FADTC and FAENDTC provides the timing of each puff. The individual puff data for the morning session are not shown. Note the data for PUFFS Puffs 2-9 are not shown to save space.
Rows 12-15:	Show the various measurements recorded for subject 4001. Only a few rows are shown to save space.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	SPTOBID	FASEQ	FALNKID	FASPID	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FAORRESU	FASTRESC	FASTRESU	VISITNUM	FADTC	FAENDTC	FATPT
1

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

1

PUFF TOT

Total Number of Puffs

e-nicotine liquid

PUFF TOPOGRAPHY

10

PUFFS

10

PUFFS

2

2020-07-15T09:00

2020-07-15TT9:45

AM

2

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

2

1

PUFF 1

PUFFVOL

Puff Volume

e-nicotine liquid

PUFF TOPOGRAPHY

36.7

mL/sec

37

mL/sec

2

2020-07-15T09:01.36

2020-07-15T09:01.38

AM

3

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

3

1

PUFF 1

AVGFLOW

Average Flow rate

e-nicotine liquid

PUFF TOPOGRAPHY

15.5

mL/sec

15.5

mL/sec

2

2020-07-15T09:01.36

2020-07-15T09:01.38

AM

4

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

4

1

PUFF 1

PKFLOW

Peak Flow Rate

e-nicotine liquid

PUFF TOPOGRAPHY

20.5

mL/sec

20.5

mL/sec

2

2020-07-15T09:01.36

2020-07-15T09:01.38

AM

5

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

5

1

PUFF 1

PUFFDUR

Puff Duration

e-nicotine liquid

PUFF TOPOGRAPHY

2.0

msec

1.6

msec

2

2020-07-15T09:01.36

2020-07-15T09:01.38

AM

6

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

6

2

PUFF TOT

Total Number of Puffs

e-nicotin liquid

PUFF TOPOGRAPHY

9

PUFFS

9

PUFFS

2

2020-07-15T03:00

2020-07-15T03:30

PM

7

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

7

2

PUFF 10

INTPUFIN

Puff Interval

e-nicotine liquid

PUFF TOPOGRAPHY

910396.8

sec

910396.8

sec

2

2020-07-15T03:30:34

2020-07-15T03:30:36

PM

8

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

8

2

PUFF 10

PUFFVOL

Puff Volume

e-nicotine liquid

PUFF TOPOGRAPHY

43

mL/sec

43

mL/sec

2

2020-07-15T03:30:34

2020-07-15T03:30:36

PM

9

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

9

2

PUFF 10

AVGFLOW

Average Flow rate

e-nicotine liquid

PUFF TOPOGRAPHY

14.5

mL/sec

14.5

mL/sec

2

2020-07-15T03:30:34

2020-07-15T03:30:36

PM

10

TGI400

TOPT001

FA

3001

PUFANYXYZ

EC-333

10

2

PUFF 10

PKFLOW

Peak Flow Rate

e-nicotine liquid

PUFF TOPOGRAPHY

22.5

mL/sec

22.5

mL/sec

2

2020-07-15T03:30:34

2020-07-15T03:30:36

PM

12

TGI400

TOPT001

FA

4001

PUFANYXYZ

EC-333

1

PUFF TOT

Total Number of Puffs

e-nicotine liquid

PUFF TOPOGRAPHY

10

PUFFS

10

PUFFS

2

2020-08-15T9:00

2020-08-15TT9:45

AM

13

TGI400

TOPT001

FA

4001

PUFANYXYZ

EC-333

2

1

PUFF 1

PUFFVOL

Puff Volume

e-nicotine liquid

PUFF TOPOGRAPHY

34.7

mL/sec

34

mL/sec

2

2020-08-15T09:01.36

2020-08-15T09:01.38

AM

14

TGI400

TOPT001

FA

4001

PUFANYXYZ

EC-333

3

1

PUFF 1

AVGFLOW

Average Flow rate

e-nicotine liquid

PUFF TOPOGRAPHY

15.5

mL/sec

15.5

mL/sec

2

2020-08-15T09:01.36

2020-08-15T09:01.38

AM

15

TGI400

TOPT001

FA

4001

PUFANYXYZ

EC-333

4

1

PUFF 1

PKFLOW

Peak Flow Rate

e-nicotine liquid

PUFF TOPOGRAPHY

23.5

mL/sec

23.5

mL/sec

2

2020-08-15T09:01.36

2020-08-15T09:01.38

AM

The RELREC dataset was used to record the relationship between the Exposure records in EX and the records in FAEX.

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