Authors’ contributions
TB, MP
MS conceived the initial studies. MS and TBE initiated the initial case series, and FMP, AG, GC, and MS initiated the non-clinical studies, together establishing the current study concept and rational. All authors made contributions to the conception and/or the trial design. TF and MS wrote and revised the study protocol. MF, CF, MP, TB, IB, KM, and RK made contributions to the study protocol and revised the final protocol for content. RK has the main responsibility for statistical analyses and made substantial contributions to the study protocol. TF contributed decisively to ethics approval to ethics and regulatory authorities. MF is the sponsor’s delegated person. MS is the sponsor’s delegated clinician. TF is responsible for the implementation of the study. TF and MS wrote and revised the manuscript. RK developed the statistical concept and performed the sample size calculation. MF, CF, MP, IB, KM, TB, WE, TM, FMP, AG, and GC revised the final manuscript for content. All authors read and approved the final manuscript.