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Article History

Received: 16 March 2018

Accepted: 29 May 2018

First Online: 8 June 2018

Ethics approval and consent to participate

: The study was approved by the Institutional Review Board of University of Wisconsin at Madison. Need for signed consent and assent was waived because this study presents a minimal risk for the breach of confidentiality to subjects. The waiver did not adversely affect the rights and welfare of subjects. Confidentiality protections are in place. The research could not practicably be carried out without a waiver of informed consent since the large volume of research subjects proposed along with the difficulty that many patients are lost to follow-up and the time to get permission of each patient for the outcomes analysis would not be practical. In addition, clinical care for patients will already be completed when those patients data will be extracted from the medical records for use in future outcomes analysis done under the IRB protocol. Therefore, it was deemed impractical by the aforementioned IRB to obtain consent from these subjects.

: The authors declare that they have no competing interests.

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