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Together, the cumulative effect on heart rate and blood pressure becomes clinically significant, particularly for patients with pre-existing cardiovascular disease, uncontrolled hypertension, or arrhythmias

In both letters, the agency warned that unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. One vendorGorilla Healingnow has an FDA disclaimer added to its site about its products

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[4] Shen ZY, Chen YR, Wang MC, Chang SS

stronger evidence comes from subsequent studies like the 2016 Lee et al

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