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Normal levels would rule out pituitary or thyroid issues to be causing the menstrual irregularities, and supports the diagnosis of PCOS if your other reproductive hormone testing showed abnormalities that would lead to a hormonal imbalance

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[iv] Finally, a number of additional factors may influence the design of first-in-human clinical trials, including the presence or absence of biomarkers, the suitability of the selected preclinical models, and the demographic characteristics of the study participants