Text and Data Mining valid from 2019-07-27
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.