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Can the proposed analysis plan use both retrospective data and prospective data?

Yes, as long as the analysis includes a minimum of four years of follow up data and can be completed within 36 months. PCORI anticipates that at least four years of retrospective data are available for investigators to address multiple comparisons of both medication classes and individual medications inclusive of a minimum of four years of follow-up data. In addition to the analysis of retrospective data, some prospective data collection is permitted to meet the 4-year follow-up requirement if its collection can be completed within the 36-month study period of performance.

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