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if clinical criteria werent met, provide additional evidence or explain why criteria should be waived

10.1016/J.TCB.2008.10.003 94 MossJ

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In the STEP 1 trial, participants taking a 2.4 mg weekly dose achieved a mean total body weight reduction of 14.9 percent over 68 weeks (Source: STEP 1 Trial, Wilding et al., NEJM 2021)

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