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Comment: I'm updating references to domain section numbers after reorganizing product description domain order

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Nametx
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Rows 1-22:Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.
Rows 23-44:Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the vehicle control (i.e., Strain of TA100, positive control with a concentration value of 2). SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Rows 13, 35:

Show a value for SPTOBID=CIG01a.  SPTOBID is Sponsor-Defined Tobacco Product ID that is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2 Product Design Parameters and Conformance Testing Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a.

The TO domain is described in the Section 2.8.8.6 1 Tobacco Product Identifiers and Descriptors (TO).

Rows 21, 43:

Show a value for SPDEVID.  SPDEVID is the Sponsor defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset. The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the di.xpt in SDTM Example.Product HPHC ENDS Testing.

The DI domain is described in the Section 2.8.9.7 Device Identifiers (DI).

Rows 22, 44:

Show a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the du.xpt in SDTM Example.Product HPHC ENDS Testing.

The DU domain is described in the Section 2.8.9.8 Device-In-Use (DU).

Dataset2
RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA

A-TA98-C01SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetAA-TA98-C02STRAINStrain/SubstrainTA98
38325064AmesTX

SetA

A-TA98-C03METACTMetabolic ActivationNOT APPLICABLE
48325064AmesTX

SetA

A-TA98-C04METACTFLY/N presence of metabolic activationN
58325064AmesTXSetAA-TA98-C05TRTDMINTreatment Duration Minimum71.5
68325064AmesTXSetAA-TA98-C06TRTDTRGTreatment Duration Target72
78325064AmesTXSetAA-TA98-C07TRTDMAXTreatment Duration Maximum72.5
88325064AmesTXSetAA-TA98-C08TRTDUTreatment Duration UnitHOURS
98325064AmesTXSetAA-TA98-C09INCBTMPIncubation Temperature37
108325064AmesTXSetAA-TA98-C010INCBTMPUIncubation Temperature UnitC
118325064AmesTXSetAA-TA98-C011HUMIDAtmospheric Relative Humidity Percent50
128325064AmesTXSetAA-TA98-C012ATMCO2Atmospheric CO2 Percent5
138325064AmesTXSetAA-TA98-C013SPTOBID

Sponsor defined tobacco identifier

CIG01a
148325064AmesTXSetAA-TA98-C014EXPTYP

Exposure Type

Submerged
158325064AmesTXSetAA-TA98-C015SAMTYP

Sample Type

Total Particulate Matter in PBS
168325064AmesTXSetAA-TA98-C016INTRVN

Name of the intervention article

TA1
178325064AmesTXSetAA-TA98-C017ITVTYPE

Type of intervention article

Vehicle Control
188325064AmesTXSetAA-TA98-C018ITVCONCConcentration of intervention article0
198325064AmesTXSetAA-TA98-C019ITVCONCUConcentration Unitug/plate
208325064AmesTXSetAA-TA98-C020TRTVTreatment VehicleDMSO
218325064AmesTXSetAA-TA98-C021SPDEVIDSponsor defined device identifierPUFFMASTER3K
228325064AmesTXSetAA-TA98-C022DUREFIDSmoke RegimenNON-INTENSE REGIMEN
238325064AmesTX

SetR

R-TA100-C21SPECIESSpeciesSalmonella typhimurium
248325064AmesTX

SetR

R-TA100-C22STRAINStrain/SubstrainTA100
258325064AmesTX

SetR

R-TA100-C23METACTMetabolic ActivationNOT APPLICABLE
268325064AmesTX

SetR

R-TA100-C24METACTFLY/N presence of metabolic activationN
278325064AmesTX

SetR

R-TA100-C25TRTDMINTreatment Duration Minimum71.5
288325064AmesTX

SetR

R-TA100-C26TRTDTRGTreatment Duration Target72
298325064AmesTX

SetR

R-TA100-C27TRTDMAXTreatment Duration Maximum72.5
308325064AmesTX

SetR

R-TA100-C28TRTDUTreatment Duration UnitHOURS
318325064AmesTX

SetR

R-TA100-C29INCBTMPIncubation Temperature37
328325064AmesTX

SetR

R-TA100-C210INCBTMPUIncubation Temperature UnitC
338325064AmesTX

SetR

R-TA100-C211HUMIDAtmospheric Relative Humidity Percent50
348325064AmesTX

SetR

R-TA100-C212ATMCO2Atmospheric CO2 Percent5
358325064AmesTX

SetR

R-TA100-C213SPTOBID

Sponsor defined tobacco identifier

CIG01a
368325064AmesTX

SetR

R-TA100-C214EXPTYP

Exposure Type

Submerged
378325064AmesTX

SetR

R-TA100-C215SAMTYP

Sample Type

Total Particulate Matter in PBS
388325064AmesTX

SetR

R-TA100-C216INTRVN

name of the intervention article

TA1
398325064AmesTX

SetR

R-TA100-C217ITVTYPE

type of intervention article

Positive Control
408325064AmesTX

SetR

R-TA100-C218ITVCONCConcentration of intervention article2
418325064AmesTX

SetR

R-TA100-C219ITVCONCUConcentration Unitug/plate
428325064AmesTX

SetR

R-TA100-C220TRTVTreatment VehicleDMSO
438325064AmesTX

SetR

R-TA100-C221SPDEVIDSponsor defined device identifierPUFFMASTER3K
448325064AmesTX

SetR

R-TA100-C222DUREFIDSmoke RegimenNON-INTENSE REGIMEN

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