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title	tx.xpt (trial sets)

How do we handle "toxic, no revertant colonies"? (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
Condition of background bacterial lawn? Slight thinning, Very thin? - refer to SEND team's marked-up table.
- new Test code of Cytotoxicity with GTORRES = S, V (controlled terms)
- Each plate we would have one result record for Revertent count and another for the lawn evaluation (NORMAL, SLIGHT THINNING, VERY THIN)
When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)

Below the SETS shown in the TX table are rows A, F, I, and R (probably don't need R)

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Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetA	A-TA98-C0	1	SPECIES	Species	Salmonella typhimurium
2	8325064	Ames	TX	SetA	A-TA98-C0	2	STRAIN	Strain/Substrain	TA98
3	8325064	Ames	TX	SetA (Row 1)SetA	A-TA98-C0	3	METACT	Metabolic Activation
4	8325064	Ames	TX	SetA	A-TA98-C0	4	METACTFL	Y/N presence of metabolic activation	N
5	8325064	Ames	TX	SetA	A-TA98-C0	5	TRTDMIN	Treatment Duration Minimum	71.5
6	8325064	Ames	TX	SetA	A-TA98-C0	6	TRTDTRG	Treatment Duration Target	72
7	8325064	Ames	TX	SetA	A-TA98-C0	7	TRTDMAX	Treatment Duration Maximum	72.5
8	8325064	Ames	TX	SetA	A-TA98-C0	8	TRTDU	Treatment Duration Unit	HOURS
9	8325064	Ames	TX	SetA	A-TA98-C0	9	INCBTMP	Incubation Temperature	37
10	8325064	Ames	TX	SetA	A-TA98-C0	10	INCBTMPU	Incubation Temperature Unit	C
11	8325064	Ames	TX	SetA	A-TA98-C0	11	HUMID	Atmospheric Relative Humidity Percent	50
12	8325064	Ames	TX	SetA	A-TA98-C0	12	ATMCO2	Atmospheric CO2 Percent	5
13	8325064	Ames	TX	SetA	A-TA98-C0	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
14	8325064	Ames	TX	SetA	A-TA98-C0	14	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
15	8325064	Ames	TX	SetA	A-TA98-C0	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
16	8325064	Ames	TX	SetA	A-TA98-C0	16	INTRVN	name of the intervention article	TA1
17	8325064	Ames	TX	SetA	A-TA98-C0	17	ITVTYPE	type of intervention article	Vehicle Control
18	8325064	Ames	TX	SetA	A-TA98-C0	18	ITVCONC	Concentration of intervention article	0
19	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVCONCU	Concentration Unit	ug/plate
20	8325064	Ames	TX	SetA	A-TA98-C0	20	TRTV	Treatment Vehicle	DMSO
21	8325064	Ames	TX	SetA	A-TA98-C0	21	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
22	8325064	Ames	TX	SetA	A-TA98-C0	22		DUREFID	Smoke Regimen	Medium Intensity Regimen
	8325064	Ames	TX	SetF (row 6)	F-TA98-C500	1	SPECIES	Species
	8325064	Ames	TX	SetF		2	STRAIN	Strain/Substrain
23	8325064	Ames	TX	SetF		3	METACT	Metabolic Activation (should there be two parms? Presence, type)?	None	Activation
	8325064	Ames	TX	SetF	TRTDRTRG		4	METACTFL	Y/N presence of metabolic activation	NTreatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetF			TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetF			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetF			INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	TA1
	8325064	Ames	TX	SetF			ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
	8325064	Ames	TX	SetF			ITVCONC	Concentration of intervention article	500
	8325064	Ames	TX	SetF			ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetF			STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetF			REGIME	Smoking Regime	ISO Regime
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	8325064	Ames	TX	SetG (row 7) do G not I!!!			METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetI (row 9)SetG			TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetISetG			TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetISetG			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetISetG			INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	2-Nitrofluorine
	8325064	Ames	TX	SetISetG			ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetISetG			ITVCONC	Concentration of intervention article	5
	8325064	Ames	TX	SetISetG			ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetISetG			REGIME	Smoking Regime	ISO
...				SetG
	8325064	Ames	TX	SetR (Row 18)			METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetR			TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetR			TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetR			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetR			INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	4-Nitroquinoline-1-oxide
	8325064	Ames	TX	SetR			ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetR			ITVCONC	Concentration of intervention article	2
	8325064	Ames	TX	SetR			ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetR			STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetR			REGIME	Smoking Regime	ISO

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Key

SET (what sponsor calls it)