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  • A study protocol version in which study subjects or experimental units are assigned by an investigator based on a protocol to receive specific interventions. EXAMPLE(S): Version dates for \'A Randomizaed Phase 3 Trial of Treatment 1 and Treatment 2 in Patients with Stage III Colon Cancer\' VERSION 1: Activation February 10, 2004 VERSION 2: Addendum 7 January 4, 2008 VERSION 3: Addendum 8 May 12, 2008 OTHER NAME(S): NOTE(S): Study subjects or experimental units may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The study subjects or experimental units are then followed and biomedical and/or health outcomes are assessed.
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