4.2. Selection of Participants in the Study
Ethical approval for the trial was obtained from the Ethics Committee of the Universitat Politècnica de València (Valencia, Spain). A total of 11 healthy volunteers from different countries in South America and Europe, who met the inclusion and exclusion criteria established for the study, were recruited for the trial. Inclusion criteria included age within the range of 18–40 years, with a normal body mass index (BMI between 19 and 29 kg/m