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titletx.xpt (trial sets)
  • Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor applicant designations as specified in the trial design.
  • During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
  • Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
1123NRUTX1-1-A
(plate-col-row in the 96-well plate)
CSC-10
(through SLS-200)

PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-ACSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-ACSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-ACSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-ACSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-ACSC-10
ITVCONCUintervention unitug/ml
7123NRUTX1-1-ACSC-10
STRAINStrain/SubstrainSalmonella enterica enterica
8123NRUTX1-1-ACSC-10
REGIMESmoking RegimeTraditional combustible 
9123NRUTX1-1-ACSC-10
RUN

Assay run number

1

10

123NRUTX1-1-ACSC-10
PORTPort ID1
11123NRUTX1-1-ACSC-10
SMPLIDSample ID030001
12123NRUTX1-1-ACSC-10
SMKFRCSmoke FractionA
13123NRUTX1-1-ACSC-10
REPNUMReplicate Number1
1123NRUTX1-1-BCSC-10
PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-BCSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-BCSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-BCSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
7123NRUTX1-1-BCSC-10
STRAINStrain/SubstrainSalmonella enterica enterica
8123NRUTX1-1-BCSC-10
REGIMESmoking RegimeTraditional combustible 
9123NRUTX1-1-BCSC-10
RUN

Assay run number

1

10

123NRUTX1-1-BCSC-10
PORTPort ID1
11123NRUTX1-1-BCSC-10
SMPLIDSample ID030001
12123NRUTX1-1-BCSC-10
SMKFRCSmoke FractionA
13123NRUTX1-1-BCSC-10
REPNUMReplicate Number1




















14123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
15123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
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123NRUTX1-10-HSLS-10
PLATENUMPlate number1  

123NRUTX1-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX1-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX1-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX1-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX1-10-HSLS-10
ITVCONCUintervention unitug/ml
...


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123NRUTX2-10-HSLS-10
PLATENUMPlate number2

123NRUTX2-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX2-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX2-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX2-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX2-10-HSLS-10
ITVCONCUintervention unitug/ml

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