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• A Trial Set is a planned set of one or more subjects, possessing experimental factors, treatment factors, or sponsor-defined attributes that differentiate the set from other Trial Sets on the same trial.
• Any subject that is selected for the study will be in one and only one Trial Set (i.e., Trial Sets are mutually exclusive and do not overlap).
• The Trial Set is associated with a single Trial Arm (the set of subjects assigned to a treatment strategy). More than one Trial Set may be associated with the same Arm; however, any Trial Set should be associated with only one Arm only. If a Trial Set appears to be associated with multiple Trial Arms, then it should be further subdivided into Trial Sets, each of which is associated with one Arm through the use of treatment strategy as an experimental factor.

Trial Sets – TX_

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