 - Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy participants enrolled in this clinical investigation. More specifically for serum creatinine, hepatic transaminase enzymes aspartate aminotransferase, alanine aminotransferase, and total bilirubin unless the Participant has documented Gilbert syndrome should not exceed the upper laboratory normal and haemoglobin must be equal or higher than the lower limit of the normal range, Regulations 