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  • An activity that is intended to occur at some point in the context of a particular study and that is the assignment of an experimental unit to a portion of the study, such as an arm or a portion of an arm (when secondary allocations may occur) based on a randomization book. NOTE(S): A randomization book is a predefined set of assignments to portions of a study based on criteria, such as stratum group for example, that ensures a desired distribution of subjects across those portions of the study. For example, the book entries indicate which arm a given subject, Joe, is assigned to based on the fact that he\'s the 5th person in stratum group #2.
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