Author contributions
TB, DM, NB
HSR
Substantial contribution to the conception or design of the trial: PS, TB, NB, DM, HSR. Substantial contributions to the acquisition, analysis, or interpretation of the data: all authors. Drafting the work or revising it critically for important intellectual content: all authors. Final approval of submitted version: all authors. Agreement to be personally accountable for contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature: all authors. All authors read and approved the final manuscript.