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Address causes - Treating underlying medical conditions causing deficiency, like autoimmune disorders or celiac disease, is important

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If side effects become unmanageable, you can step back to the previous dose and try escalating again after another four weeks

Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care

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