Document is current

Article History

Received: 17 May 2019

Accepted: 17 July 2019

First Online: 27 July 2019

Ethics approval and consent to participate

: IRB approval was obtained from each institution’s IRB; there were 55 sites in the randomized controlled trial. Each patient provided written informed consent prior to study enrollment.

: Not applicable.

: MDD and GMA are paid consultants for Cook Medical. AEL is a paid employee of Cook Research Incorporated, a contract research organization and Cook Group Company.