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2000s: Male erectile-response and female-arousal studies Afterward, early clinical trials evaluated intranasal PT-141 in healthy men, men with erectile dysfunction, and women with sexual-arousal concerns
An interim analysis was planned after two thirds of the total events had accrued with clear stopping rules and an alpha spending function to account for this interim look (in fact, the interim analysis did not take place until 741 events, out of the planned 854, took place)
These patients may have visceral adiposity, insulin resistance, or unfavorable lipid profiles despite appearing healthy by BMI standards