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Article History

Received: 5 December 2022

Accepted: 17 January 2023

First Online: 27 March 2023

Declarations

:

: Ethics approval was granted from the Western University Research Ethics Board through Clinical Trials Ontario (CTO #0733). Written, informed consent to participate will be obtained from all participants or their Substitute Decision Maker (SDM). All centres participating in the study get their own ethics committee approval.

: Not applicable; consent for publication of trial results or protocol not required as no identifying information of participants will be shared.

: The authors declare they have no direct competing interests in the study. The study received partial industry funding through the first grant which was a CIHR-industry partnership, with the industry partner at arm’s length. The industry partner, Medtronic, has no role in the study design, data collection, analysis, interpretation or publication of manuscript. No author received personal financial remuneration for the study. The authors declare no other competing interests in the study.