doi.org/00.00000/protocols.io.bcqjivun)) received ethical clearance from the ethics committees of the Fondazione IRCCS Istituto Neurologico Carlo Besta (0 February 0000, internal ref: 00; amendment approved 00 September 0000, internal ref: 00) and The University of Queensland (0 May 0000, clearance number: 0000000000/Review 00000000). All participants gave written informed consent. The study was registered on the ISRCTN registry (ISRCTN registration number: 00000000), 0 June 0000, before enrolment completion. The authors confirm that all ongoing and related trials for this intervention are registered.