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title	tx.xpt (trial sets)

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
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 designations as specified in the trial design.
Do we need "plate counted manually", how is this typically shared in current submissions?
How do we handle "toxic, no revertant colonies"?
Condition of background bacterial lawn? Slight thinning, Very thin? - refer to SEND team's marked-up table.
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)

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetA (Row 1)	METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
2	8325064	Ames	TX	SetA	TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
3	8325064	Ames	TX	SetA	TRTDRTOL	Treatment Duration Tolerance
4	8325064	Ames	TX	SetA	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
5	8325064	Ames	TX	SetA	INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	DMSO. (or TA1)
6	8325064	Ames	TX	SetA	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Vehicle Control. (or Product)
7	8325064	Ames	TX	SetA	ITVCONC	Concentration of intervention article	0 (null?)
8	8325064	Ames	TX	SetA	ITVCONCU	Concentration Unit	ug/plate
9	8325064	Ames	TX	SetA	STRAIN	Strain/Substrain	TA98
10	8325064	Ames	TX	SetA	REGIME	Smoking Regime	ISO
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	8325064	Ames	TX	SetF (row 4)	METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetF	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	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)	2-Nitrofluorine
	8325064	Ames	TX	SetF	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	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
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	8325064	Ames	TX	SetI(row 6)	METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetI	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	SetI	TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetI	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetI	INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	2-Nitrofluorine
	8325064	Ames	TX	SetI	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetI	ITVCONC	Concentration of intervention article	5
	8325064	Ames	TX	SetI	ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetI	STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetI	REGIME	Smoking Regime	ISO
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	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)