Author contribution
JP, MM
MM devised the project and main conceptual ideas together with AEV, HWG, and MAAJ. AEV, MAAJ, and HWG worked out technical details and study design. AEV coordinated the clinical trial under supervision of MM and MAAJ. BCEM and SJWK performed the clinical evaluations. NK carried the medical responsibility. HWG and AEV designed assays and coordinated bioanalysis. TDW and MS performed bioanalysis. AEV, HWG, JLP, MAAJ, and MM analyzed and interpreted data. MLK carried out the statistical analysis. MM, AEV, MAAJ, HWG, and JP wrote the manuscript. All authors provided critical feedback and helped in shaping the manuscript.