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Article History

Received: 9 March 2021

Accepted: 20 July 2021

First Online: 3 August 2021

Declarations

:

: The study will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO) [,]. The BeBoP trial has been approved by an independent ethics committee of the sponsor, Amsterdam University Medical Centres location VUmc, for all study centres (reference number 2018.394) on February 12, 2019. A data safety monitoring board and interim analysis were not deemed required by the Medical Ethics Committee (Institutional Review Board, IRB). A member of the independent Clinical Research Bureau VUmc will audit the study. We will report all SAEs occurring during the first 12 months after enrolment of outpatient oral antibiotic treatment to the IRB. SAEs regarding antibiotics will be bundled and reported to the IRB every 6 months. Furthermore, we will report all SAEs and AEs in an annual safety report. The sponsor has a liability insurance which is in accordance with the legal requirements in The Netherlands.Subjects will be recruited at one of the participating centres. If subjects meet the inclusion criteria, they will be informed about the study by the physician of the diabetic foot team, who will ask for informed consent and will provide verbal and written information approved by the IRB. Important protocol modifications will be communicated to investigators by protocol disseminations and face-to-face meetings. The IRB will be asked for approval by amendment submission.

: Not applicable.

: The authors declare that they have no competing interests.