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Additional violations included: No documented monitoring plan or monitoring reports Enrollment of ineligible subjects (e.g., with low platelet counts) Inadequate documentation of informed consent Unreported adverse device effects (UADEs) Inaccurate device accountability records Why It Matters: Sponsors are legally and ethically accountable for the oversight of their clinical trials

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Patients begin with 0.25 mg and ramp up to the FDA-approved dose of 2.4 mg over 20 weeks

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