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Across analyses, a recurring contrast is observed between (i) a reproductive subtypeoften reported as higher LH and SHBG with elevated androgens despite comparatively lower BMI and fasting insulinand (ii) a metabolic subtype, characterized by higher adiposity with higher glucose/insulin measures and lower SHBG (and, in some reports, lower LH) ( n = 11,908), four sub-phenotypes were identified, broadly echoing this metabolicreproductive axis and showing substantial overlap with NIH-based subtyping frameworks ( From a reproductive endocrine perspective, canonical PCOS is characterized by: (i) hyperandrogenism, presenting as hirsutism, acne, and androgenetic alopecia, with elevated total/free testosterone, an increased free androgen index (FAI), and occasionally elevated dehydroepiandrosterone sulfate (DHEAS)

The approval was granted based on data from the Phase III NEURO-TTRansform study, where treatment with Wainua significantly reduced serum concentrations of the transthyretin (TTR) protein and significantly improved neuropathy impairment