 20. Subjects identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member i.e. parent, spouse, natural or adopted child of the Investigator or employee with direct involvement in the proposed study or any employee of Medicago. Immediate family members of the Investigator or employees of a clinical site can participate in the study at another clinical site, as long as the Investigator or employees are not involved in the study at that site; 