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For purposes of this paragraph (d), an extraordinary circumstance is an event beyond the control of an ASC (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the ASC to comply with one or more applicable reporting requirements with respect to a calendar year

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Higher daily-loading models (100-200 mg daily for 7-10 days) appear in clinic protocols and are typically reserved for supervised settings

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When side effects occur, many users report that symptoms are temporary and resolve after treatment adjustments or discontinuation