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In the recent SCALE Intensive Behavioral Therapy phase 3b trial, participants were encouraged to attend scheduled visits and thus have their weight measurements recorded regardless of discontinuing treatment [8]

We considered asking the official to submit their MRF attestation directly to CMS, using a CMS developed template that would provide evidence of the accuracy and completeness of the MRF, and we also considered requiring the hospitals to post a more detailed attestation document that is signed by a senior official on the publicly available website that hosts the MRF

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Refrigerate at 4 C (39 F) immediately upon receipt and during active use