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Dataset wrap
Nametx.xpt
Rowcaps
Rows 1-23:

Show trial set parameters and trial set values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short term exposure and metabolic activation S9.  The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".

Set A1 is associated with the first row in the sample report table for study 123.

Rows 24-46:

Show trial set parameters and trial set values that comprise the test conditions for trial set A2. Set A2 is the data for the short term exposure with metabolic activation S9 at a concentration of 1250 ug/ml.  The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250".

Set A2 is associated with the second row in the sample report table for study 123.

Dataset2
RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNvitTX

A1

ST+S9_C02METACTMetabolic Activation+S9
2123MNvitTXA1ST+S9_C03METACTFLY/N presence of metabolic activationY
3123MNvitTX

A1

ST+S9_C04TRTDMINTreatment Duration Minimum3
4123MNvitTXA1ST+S9_C05TRTDTRGTreatment Duration Target3.5
5123MNvitTXA1ST+S9_C06TRTDMAXTreatment Duration Maximum4
6123MNvitTX

A1

ST+S9_C07TRTDUTreatment Duration UnitHOURS
7123MNvitTXA1ST+S9_C08RCVDMINRecovery Duration Minimum23.5
8123MNvitTXA1ST+S9_C09RCVDTRGRecovery Duration Target24
9123MNvitTX

A1

ST+S9_C010RCVDMAXRecovery Duration Maximum24.5
10123MNvitTXA1ST+S9_C011RCVDURecovery Duration UnitHOURS
11123MNvitTXA1ST+S9_C012INCBTMPIncubation Temperature37
12123MNvitTX

A1

ST+S9_C013INCBTMPUIncubation Temperature UnitC
13123MNvitTXA1ST+S9_C014HUMIDAtmospheric Relative Humidity Percent50
14123MNvitTX

A1

ST+S9_C015ATMCO2Atmospheric CO2 Percent5
15123MNvitTXA1ST+S9_C016

SPTOBID

Sponsor defined tobacco identifier

CIG01a
16123MNvitTXA1ST+S9_C017EXPTYP

Exposure Type

Submerged
17123MNvitTXA1ST+S9_C018SAMTYP

Sample Type

Total Particulate Matter in DMSO
18123MNvitTXA1ST+S9_C019INTRVN

Name of the Intervention Article

Tobacco ProdA
19123MNvitTXA1ST+S9_C020ITVTYPE

type of intervention article

Negative Control
20123MNvitTXA1ST+S9_C021ITVCONCConcentration of intervention article0
21123MNvitTXA1ST+S9_C022ITVCONCUConcentration Unitug/ml
22123MNvitTXA1ST+S9_C023

SPDEVID

Sponsor defined device identifierPUFFMASTER3K
23123MNvitTXA1ST+S9_C024

DUREFID

Smoke RegimenMedium Intensity Regimen
24123MNvitTX

A2

ST+S9_C12502METACTMetabolic Activation+S9
25123MNvitTXA2ST+S9_C12503METACTFLY/N presence of metabolic activationY
26123MNvitTXA2ST+S9_C12504TRTDMINTreatment Duration Minimum3
27123MNvitTXA2ST+S9_C12505TRTDTRGTreatment Duration Target3.5
28123MNvitTXA2ST+S9_C12506TRTDMAXTreatment Duration Maximum4
29123MNvitTXA2ST+S9_C12507TRTDUTreatment Duration UnitHOURS
30123MNvitTXA2ST+S9_C12508RCVDMINRecovery Duration Minimum23.5
31123MNvitTXA2ST+S9_C12509RCVDTRGRecovery Duration Target24
32123MNvitTXA2ST+S9_C125010RCVDMAXRecovery Duration Maximum24.5
33123MNvitTXA2ST+S9_C125011RCVDURecovery Duration UnitHOURS
34123MNvitTXA2ST+S9_C125012INCBTMPIncubation Temperature37
35123MNvitTXA2ST+S9_C125013INCBTMPUIncubation Temperature UnitC
36123MNvitTXA2ST+S9_C125014HUMIDAtmospheric Relative Humidity  Percent50
37123MNvitTXA2ST+S9_C125015ATMCO2Atmospheric CO2 Percent5
38123MNvitTXA2ST+S9_C125016SPTOBID

Sponsor defined tobacco identifier

CIG01a
39123MNvitTXA2ST+S9_C125017EXPTYP

Exposure Type

Submerged
40123MNvitTXA2ST+S9_C125018SAMTYP

Sample Type

Total Particulate Matter in DMSO
41123MNvitTXA2ST+S9_C125019INTRVN

Name of the Intervention Article

Tobacco ProdA
42123MNvitTXA2ST+S9_C125020ITVTYPE

type of intervention article

Product
43123MNvitTXA2ST+S9_C125021ITVCONCConcentration of intervention article1250
44123MNvitTXA2ST+S9_C125022ITVCONCUConcentration Unitug/ml
45123MNvitTXA2ST+S9_C125023SPDEVIDSponsor defined device identifierPUFFMASTER2023
46123MNvitTXA2ST+S9_C125024DUREFIDSmoke RegimenHigh Intensity Regimen
A
Dataset wrap
Rowcaps
Row 1:Shows the value of REFID=A, This REFID refers to the trial set with a SETCD of 'SetA', as defined in the trial set dataset, tx.xpt.  LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 2-6:Show the values of five observational units 0_1 through 0_5 that are within the parent experimental unit, REFID=A
Rows 12-14:
Row 15:
Rows 16-18:
Dataset2
tableidrelref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

123

MNvit

A!

C0
1

TRIAL SET

2

123

MNvit

A1

C0-C1C02OBSERVATIONAL UNIT

3

123

MNvit

A!

C0-C2C02OBSERVATIONAL UNIT

4

123

MNvit

A!

C0-C3C02OBSERVATIONAL UNIT

5

123

MNvit

A1

C0-C4C02OBSERVATIONAL UNIT

6

123

MNvit

A2C1250
1TRIAL SET
7123

MNvit

A2C1250-C1C12502OBSERVATIONAL UNIT
8123

MNvit

A2C1250-C2C12502OBSERVATIONAL UNIT
9123

MNvit

A2C1250-C3C1250
Dataset2
tableidrelref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

Ames

SetA

A

1

TRIAL SET

2

8325064

Ames

SetA

0_1

2OBSERVATIONAL UNIT
3
10
8325064
123
Ames

MNvit

SetA

0_2

A
A2C1250-C4C12502OBSERVATIONAL UNIT

4

18


A1:


A2:                                   

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