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This doesn't mean it's unsafe it means it hasn't gone through the specific regulatory pathway the FDA requires for approved drugs

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Accordingly [12,13,14,15,16,20,22,23,24], superior sagittal sinus pressure of 24 to 27 mmHg, portal pressure of 35 mmHg, similar to that of the inferior vena cava although with values at least 1 mmHg higher in the portal vein, and abdominal aorta blood pressure values of 100120 mmHg at the level of the bifurcation were considered as normal in healthy rats