Author contributions
TB, MM
MM devised the project and main conceptual ideas together with SA, TB, NT, and MJ. SA, TB, MJ, and MM worked out technical details and study design. SA and TB coordinated the clinical trial. PH coordinated and performed bioanalysis. NK carried the medical responsibility. SA, TB, MM, MJ, CH, and PH analyzed and interpreted data. MK carried out statistical analysis. SA, TB, MJ, and MM wrote the manuscript. All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.