SDTM Example.Trial Inclusion

This example shows records for a trial that had 2 versions of inclusion/exclusion criteria.

Rows 1-3:	Show the 2 inclusion criteria and 1 exclusion criterion for version 1 of the protocol.
Rows 4-6:	Show the inclusion/exclusion criteria for version 2.2 of the protocol, which changed the minimum age for entry from 21 to 18.

ti.xpt

xx.xpt

Row	STUDYID	DOMAIN	IETESTCD	IETEST	IECAT	TIVERS
1	XYZ	TI	INCL01	Typically smoking menthol cigarettes	INCLUSION	1
2	XYZ	TI	INCL02	Age 21 or greater	INCLUSION	1
3	XYZ	TI	EXCL01	Pregnant or lactating	EXCLUSION	1
4	XYZ	TI	INCL01	Typically smoking menthol cigarette	INCLUSION	2.2
5	XYZ	TI	INCL02A	Age 18 or greater	INCLUSION	2.2
6	XYZ	TI	EXCL01	Pregnant or lactating	EXCLUSION	2.2

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