(Source 3) 5
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Sample size calculations were based on phase 2 trial data, which predicted a treatment difference of 1.0 in the Female Sexual Function Index-desire domain (FSFI-D) score and about 20.43 points in the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) item 13, with a total of 450 evaluable patients providing sufficient statistical power to detect significant differences
Key areas of investigation include modulation of the nitric oxide (NO) system through interaction with NOS isoforms, upregulation of growth factor receptors (including VEGFR2 and EGF receptor systems), and engagement of the FAK-paxillin signaling cascade associated with cell migration and adhesion
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