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These figures document reports received, not confirmed causation or injury rates - but they represent a real safety signal that the FDA has publicly acknowledged and acted on

Mean reductions were 8.7%, 17.1%, 22.8%, and 24.2% for the 1, 4, 8, and 12 mg groups respectively, versus only 2.1% in the placebo arm

No completed human efficacy trials

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Oral tablets offer convenience for needle-averse patients, while injections require only once-weekly dosing and have fewer timing restrictions around meals

The Medicaid portion of the coverage plan will proceed as planned, the agency spokesperson said.