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Common Side Effects: Clinical trials involving approximately 900 participants indicate that AOD-9604 is generally well-tolerated with a favorable safety profile

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Response: Regarding commenters' requests for exclusion criteria, we note that the measure methodology, including consideration of potential exclusions, was informed by extensive literature review, empiric analyses, and feedback from the TEP, PFE Work Group, and the public comment period held during measure development

20: Staresinic M, Japjec M, Vranes H, Prtoric A, Zizek H, Krezic I, Gojkovic S, Smoday IM, Oroz K, Staresinic E, Dretar V, Yago H, Milavic M, Sikiric S, Lovric E, Batelja Vuletic L, Simeon P, Dobric I, Strbe S, Kokot A, Vlainic J, Blagaic AB, Skrtic A, Seiwerth S, Sikiric P