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At 425.512(b)(4)(iv)(A)( 1 ), removing the phrase that is considered underserved
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Treatment with 8 mg ribupatide injection weekly in a randomized, double-blind, placebo-controlled Phase 2 trial conducted in China resulted in 23.6% weight loss from baseline compared to 1.7% for placebo at Week 36 when analyzed using the efficacy estimand with no observed weight loss plateau, indicating further weight loss may be possible with longer treatment duration
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