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Randomization was performed by the principal investigator at the end of baseline testing using sex-stratified tables

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After consideration of the public comments, we agree that the direct PE inputs for CPT codes 37263, 37265, 37271, and 37273 should include two drug-coated balloons (SD382) per code, as we are persuaded by commenters that two balloons are typically required due to the length of disease in the superficial femoral and popliteal segments

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