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  • A designation used to segregate study subjects into collections in order to balance the study for analysis. The stratum group is made up of a combination of stratification criterion answers, which ultimately is used to assign study subjects to arms on a study. EXAMPLE(S): A given study may want to require even distribution of gender and age so stratum groups may be defined as: males under 18, males 18 and over, females under 18, and females 18 and over.
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