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A multicentre, randomized, phase III, non-inferiority clinical treatment trial evaluating Imiquimod vs Surgery in female patients aged 18–90 years with histologically confirmed vHSIL
Primary outcome measures:
Complete clinical response (CCR) at 6 months after local imiquimod treatment or one surgical intervention. Primary analysis was per protocol with a non-inferiority margin of 20%.
Imiquimod is a safe, effective, and well accepted alternative to surgery for women with vHSIL and can be considered as first-line treatment.
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