Author contributions
N.H.
Z.D.C. conceived and designed the clinical trial, designed the correlative trial, performed data analysis and wrote the original paper. M.P.R. designed the correlative trial, performed data analysis and wrote the original paper. R.G.J. designed the correlative trial, performed data analysis and wrote original paper. K.S.-G. designed and conducted the clinical trial and reviewed and edited the original paper. S.M.L. conducted the clinical trial and reviewed and edited the original paper. I.A. conducted the clinical trial and reviewed and edited the original paper. G.A.M. conducted the clinical trial and reviewed and edited the original paper. M.M. conducted the clinical trial and reviewed and edited the original paper. P.S. conducted the clinical trial and reviewed and edited the original paper. D.S. conducted the clinical trial and reviewed and edited the original paper. D.P. conducted the clinical trial and reviewed and edited the original paper. I.M. conducted the clinical trial and reviewed and edited the original paper. G.M.-J. conducted the clinical trial and reviewed and edited the original paper. G.M. conducted the clinical trial and reviewed and edited the original paper. M.L.P.C. conducted the clinical trial and reviewed and edited the original paper. U.H. conducted the clinical trial and reviewed and edited the original paper. J.H. conducted the clinical trial and reviewed and edited the original paper. M.H.Q. conducted the clinical trial and reviewed and edited the original paper. N.H. conducted the clinical trial and reviewed and edited the original paper. T.L. conducted the clinical trial and reviewed and edited the original paper. I.G.-C. conducted the clinical trial and reviewed and edited the original paper. A.V.-H. performed data analysis and reviewed the original paper. E.S. performed data analysis and reviewed the original paper. I.G.-K. performed data analysis and reviewed the original paper. I.G. performed data analysis and reviewed the original paper. D.I. performed data analysis and reviewed the original paper. L.S.-D. performed data analysis and reviewed the original paper. S.K. provided biostatistical support, performed data analysis and contributed to the statistical section of the paper. F.G. provided biostatistical support, performed data analysis and contributed to the statistical section of paper. M.A.S. conducted the clinical trial and reviewed and edited the original paper. R.V. conducted the clinical trial and reviewed and edited the original paper. J.F.D. conceived and designed the clinical trial, designed the correlative trial and reviewed and edited the original paper.