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This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid. The subject were confined to a clinical after using 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  e-cigarettes for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit.  IF If the level, was too high, the visit ws was re-scheduled. Subjects were  were instructed to take 10 puffs on the e-cigarette. Puff topography was measured using the same device for all subjects. 

A  Study Reference domain, DI, was used to identify the device used to measure puff topography.  The provide a consistent sponsor-defined variable (SPDEVID) for linking data. Device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one device was used for all subjects in the study

Dataset wrap
Namedi
Dataset2
RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOPT001DIPUFANYXYZ1DEVTYPEDevice TypePuff Topography 

The sponsor submitted the EX domain to represent the usage of the e-cigarettes. For each subject, the usage for the two weeks are represented, and then the specified usage during the in-clinic visit are shown.    

   

Dataset wrap
Nameex
Dataset2
RowSTUDYIDDOMAINUSUBJIDEXSEQSPTOBIDEXTRTEXDOSEEXDOSUEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1TOPT001EX30011EC-333e-nicotine liquidAD LIBITUM
INHALED8mg/mL2020-06-262020-07-14
2TENDS01EX30012EC-333e-nicotine liquid10PUFFSINHALED8mg/mL2020-07-15T9:002020-07-15TT9:45
3TENDS01EX40013EC-333e-nicotine liquidAD LIBITUM
INHALED16mg/mL2020-09-062020-09-22
3TENDS01EX40014EC-333e-nicotine liquid10PUFFSINHALED16mg/mL2020-09-22T9:002020-09-22T9:30

The FAEX domain was used to represent the puff topography associated with the in -clinic visit.  A puff -by puff analysis was performed. Additionally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session.    

Dataset wrap
Nameface
Rowcaps
Row 1Shows the Number of Puff taken in the interval. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken.  
Rows 2-3, 5-6 Show the puff volume for Subject 3001 for each puff and the puff duration for Subject 4001.  FADTC and FAENDTC provides the timing of each puff. Only data for 2 puffs are shown.  
Rows 4 & 7  Shows the mean puff volume for Subject 3001 and the mean puff duration for Subject 4001for all puffs during the interval provided in FADTC and FAENDTC. The NSV variable FACOLSRT indicates that the Mean puff volume is provided. The method to calculate the mean was provided in FAMETHOD, in this situation the DEVICE ALGORITHM. 
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPDEVIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUFALOBXFLFAMETHODVISITNUMFADTCFAENDTC
FATPT
FACOLSRT
1TGI400FA3001PUFANYXYZ1PUFF TOTTOTAL NUMBER OF PUFFS e-nicotine liquid


10PUFFS10PUFFS

22020-07-15T9:002020-07-15TT9:45





1TGI400FA3001PUFANYXYZ2PUFFVOL PUFF VOLUMEe-nicotine liquid

PUFF TOPOGRAPHY

66.7ml/sec98ml/sec

2

2020-07-15T9:00



PUFF 1



2

TGI400

FA3001PUFANYXYZ3PUFFVOL PUFF VOLUME e-nicotine liquidPUFF TOPOGRAPHY43ml/sec43ml/sec

22020-07-15T9:11

PUFF 2

3

TGI400

FA3001PUFANYXYZ4PUFFVOLPUFF VOLUMEe-nicotine liquidPUFF TOPOGRAPHY53.7ml/sec53.7ml/sec
DEVICE ALGORITHM22020-07-15T9:002020-07-15TT9:45


MEAN
4

TGI400

FA4001PUFANYXYZ1PUFFDURPUFF DURATIONe-nicotine liquidPUFF TOPOGRAPHY2sec2sec

22020-07-22

PUFF 1

5

TGI400

FA4001PUFANYXYZ2PUFFDURPUFF DURATIONe-nicotine liquidPUFF TOPOGRAPHY1.8sec1.8sec

22020-07-22

PUFF 2 

6

TGI400

FA4001PUFANYXYZ3PUFFDURPUFF DURATIONe-nicotine liquidPUFF TOPOGRAPHY1.8sec1.8sec
DEVICE ALGORITHM22020-09-22T9:132020-09-22T9:30


MEAN



Nsvmeta
DomainFA
VariableLabelTypeRoleCODELISTOrigin
FACOLSRTCollected Summary Result TypetextNon-standard Record Qualifier(COLSTYP)CRF