 - Participants must be healthy on the basis of physical examination, medical history, 12-lead electrocardiogram ECG and vital signs performed at screening after signing the ICF, and on Day -1 of the first treatment session, if applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participants source documents 