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Preclinical toxicology is limited and not comprehensively characterized

If those trials are successful, Lilly would likely submit a New Drug Application (NDA) to the FDA, which typically takes 10 months to review

International sourcing adds another layer of complexity

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240 According to one meta-analysis, microscopic subinguinal varicocelectomy resulted in a natural (unassisted) pregnancy rate of 27.5% in men with severe oligozoospermia prior to surgery

252 A retrospective cohort study of 112,043 pregnant women and their 114,522 newborns in China found that compared to spontaneously conceived infants, those conceived with assisted reproductive techniques had more than twice the risk of having any birth defect