ACKNOWLEDGMENTS
The authors thank Petra Koopmans, PhD, Radboud University Medical Center, Department of Health Evidence, Section Biostatistics, biostatistician, for her support and review of the statistical analyses.The trial was registered at ClinicalTrials.gov (NCT04042090).This work was supported by the European Regional Development Fund (ERDF) [PROJ-00840, 2018]. The authors declare no conflict of interest.Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s 