Acknowledgements
We thank the research organization Simbec-Orion for their assistance with data management and pharmacovigilance, which greatly contributed to the overall quality of the trial, as well as for their comments to improve the manuscript. Furthermore, we would like to acknowledge the contribution of the members of the data safety monitoring board, Prof. Dr. H.R. Buller (Amsterdam University Medical Center, Amsterdam, The Netherlands), Prof. DR. L.B. Ware (Vanderbilt University, Nashville, Unites States), Dr. R.M. van Hest (Amsterdam University Medical Center, Amsterdam, The Netherlands). We are grateful for their efforts in reviewing the safety throughout the duration of the trial.