Received: 14 December 2019
Accepted: 12 March 2020
First Online: 1 April 2020
Ethics approval and consent to participate
: Approval was granted by the Independent Scientific Advisory Committee (ISAC) for Medicines and Healthcare products Regulatory Agency (ISAC Protocol 14-180R).
: Not applicable.
: PHMR, LLC, received consulting fees from Medtronic. SW, MS, and TCK received consulting fees from PHMR, LLC. RST, AM, JB, DC, and SE received consulting fees from Medtronic as advisors to the project. TT has no competing interests associated with this work.