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We will determine whether to grant an exception versus an extension using the same evaluation approach currently used in ECE determinations, on a case-by-case basis, based on the specific circumstances affecting the hospital, REH, or ASC, including circumstances impacting the operational feasibility of an extension

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10.1016/j.joca.2022.01.012 149 MakrisE

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It is precisely for this reason that use without medical supervision exposes users to risks that are still poorly understood, as robust studies on many of these substances are limited or still at the preclinical stage