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Early-phase human trials are small, well-controlled studies centered on safety, reproductive hormones, and surrogate markers such as ovarian reserve tests and sperm parameters ahead of any efficacy trials
(PubMed) Kucukgoncu S, Zhou E, Lucas KB, Tek C
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Moreover, they help answer later questions about which container was opened, when it was opened, and whether it was still inside its allowed window
estradiol patches after Bayer discontinued Climara in 2023), the FDAs removal of boxed warnings on HRT products (which accelerated prescribing), and tariff pressures on overseas pharmaceutical manufacturing
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