Funding for this research was provided by:
Received: 17 December 2020
Accepted: 13 May 2021
First Online: 21 May 2021
: The study complies with the guidelines for human studies and was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. The study was approved by the institutional review board (RMC-16-0412) clinical trial registry - NCT02805114.
: Not applicable.
: This study was sponsored by Medtronic. The authors have no competing interests declared.