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FDA also noted that the existing rodent tumour studies, which reported reduced spontaneous tumour incidence, used a single fixed dose, tested only female mice, and exposed animals for roughly five and a half months in total — too limited in scope and duration to characterise carcinogenic potential either way

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The mean physician's assessment scores for CAVERJECT and the formulation contained in CAVERJECT IMPULSE were 2.6 (SD=0.6) and 2.7 (SD=0.5), respectively, based on a scale of 0 (no tumescence) to 3 (full rigidity)