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106-108 In fact, one placebo-controlled clinical trial found maca lowered levels of free testosterone in male subjects with infertility, 109 and a small observational study involving 50 men living in the Peruvian highlands found maca users had lower testosterone-to-estradiol ratios than non-users

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For Medicare purposes, we proposed to codify the definition of “biological” as “a product licensed under section 351 of the Public Health Service Act” at §§ 414.802 and 414.902