Author contributions
PD
P.T. and P.T. conceived and designed the study, and coordinated the clinical work; M.T.D.M. coordinated biomonitoring and sample collection for PK and PD analysis; M.A. coordinated formal protocol writing and regulatory and quality issues; L.F., N.S., D.C., S.G., A.S, and V.B. recruited patients, contributed to the clinical management and critically analysed patient data; B.B. and F.M. performed and analysed radiological imaging; A.C. contributed to management of the project, O.C. analysed data for preliminary evaluation. M.L. coordinated data storage and analysis; F.T. performed statistical analysis; M.C.Z., M.R.D.F, A.B., and A.E.D.F. managed the investigational drug and supervised all pharmacy procedures; F.S. performed PD analysis. D.C. and C.R. contributed to data analysis and interpretation. E.D.D.P. provided critical advice on protocol writing and trial management. All authors critically reviewed data and approved the final manuscript draft.