4.2. Study Design, Randomization, and Treatments
The trial was registered under ClinicalTrials.gov Identifier NCT03688971 and EudraCT number 2017-003106-41. The study was performed from November 2019 to January 2022 at the Centre for Human Drug Research (Leiden, The Netherlands) following the Declaration of Helsinki principles and after obtaining ethical approval from the Stichting Beoordeling Ethiek Biomedisch Onderzoek (Assen, The Netherlands). Patients provided written informed consent prior to participation in the study. This was an evaluator- and subject-blinded parallel design evaluating the synthetic indolicidin analog, omiganan pentahydrochloride, a 12-amino-acid cationic peptide of H-Ile-Leu-Arg-Trp-Pro-Trp-Trp-Pro-Trp-Arg-Arg-Lys-NH