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It enhances the production of growth factors that aid in tissue regeneration, reduces inflammation, and protects against the harmful effects of oxidative stress

The designation acknowledges safety data gaps that preclude traditional drug compounding

Patients must be clearly informed of the risks associated with nonFDA-approved products, including potential contamination, inaccurate dosing, variable bioactivity, and the presence of impurities that may provoke adverse or unpredictable effects

When a full course produces nothing noticeable, additional courses may or may not change the outcome there's no data to guide that decision