 13. Are employed by Lilly or Boehringer Ingelheim BI that is, employees, temporary contract workers, or designees responsible for the conduct of the study. Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 