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Clinical Trials Requires FDA IND (Investigational New Drug) application IRB (Institutional Review Board) oversight Strict protocols and monitoring This is RESEARCH, not treatment 2

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Although the measure was not pilot tested in the ASC setting with facilities citing resource constraints, we believe that the instrument and methodology reasonably apply to the ASC setting as the measure concept was designed for use in both HOPDs and ASCs and many of the same surgical procedures are performed in both settings