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Purpose: Mammography, the standard method of breast cancer screening, misses many cancers, especially in dense-breasted women. We compared the performance and diagnostic yield of mammography alone versus an automated whole breast ultrasound (AWBU) plus mammography in women with dense breasts and/or at elevated risk of breast cancer.

Methods: AWBU screening was tested in 4,419 women having routine mammography (

Trial Registration: ClinicalTrials.

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