Materials and methods
The Kaunas Regional Biomedical Research Ethics Committee approved the study (number of approval BE-2-5). The study adopted a randomized, double-blind, placebo-controlled format. Written informed consent was obtained from patients or their legal representative following national regulations. Investigations were carried out according to the principles of the Declaration of Helsinki. The study was retrospectively registered in the clinicaltrials.gov database (registration number NCT 04773717).