Author contributions
H.N.
O.S.S. developed the trial design. J.F.H., M.H.P., P.W.D., M.T., M.C.N., M.C. and O.S.S. wrote the protocol. J.D.G., J.F.H., B.S., J.M., H.N., I.S.J., T.B., S.L., J.G., L.Ø., L.V., N.W., A.M.D.R., K.B.H.P., J.L., S.R.L., T.A.R., D.H.R. and O.S.S. did the clinical visits. J.D.G., M.H.P., M.R.U., M.H.S., R.O., D.C.C.J., N.L., T.T.H., V.R., R.B.J., M.T. and O.S.S. did the laboratory assays and validations. V.R. performed the bioinformatic analysis. J.D.G., M.H.P., M.R.U. and H.S. did the statistical analysis. J.D.G., M.H.P., M.R.U., P.W.D. and O.S.S. drafted the tables and figures. J.D.G. and O.S.S. drafted the article, which all authors critically revised for important intellectual content. J.D.G. and O.S.S. had full access to all the data in the study, verified the data and had final responsibility for the decision to submit for publication.