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Article History

First Online: 1 September 2018

Compliance with ethical standards

:

: None.

: None.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

: Obtaining consent was waived and approved by IRB due to the following reasons described in the IRB protocol: (A) The research is with minimal risk: it involves retrospective collection of existing data collected for non-research purposes. (B) The waiver would not adversely affect the rights and welfare of the subjects. The data will be stored using encrypted and password-protected excel files on a computer only accessible to the study team. All identifying information will be separated and destroyed at the earliest opportunity to ensure subjects are protected. These will maintain privacy and confidentiality of data. (C) Data are going to be collected from subjects who may no longer be receiving follow-up care. Obtaining consent would require additional collection of information that could increase the risk to subjects’ privacy. (D) Whenever appropriate, the subjects will be provided with additional pertinent information.