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Vomero M, Finucci A, Barbati C, Colasanti T, Ceccarelli F, Novelli L, et al

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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