10 HUMAN SUBJECTS PROTECTIONS 10.1 RATIONALE FOR SUBJECT SELECTION Subjects from all racial/ethnic groups and both genders are eligible for this study if they meet the eligibility criteria. To date, no information suggests that differences in drug metabolism, immune response, or disease response would be expected in one group compared with another. Efforts will be made to extend accrual to a representative population, but in this preliminary study, a balance must be st ruck between patient safety considerations and limitations on the number of individuals exposed to potentially toxic and/or ineffective treatments on one hand and the need to explore gender and ethnic aspects of clinical research on the other hand. If differences in outcome that correlate with ethnic identity are noted, accrual may be expanded or a follow-up study may be written to investigate those differences more fully. 10.1.1 Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial. 10.1.2 Exclusions Patients with active or chronic infections, including HIV, hepatitis B or C, innate immunodeficiency or autoimmune disease are excluded because this agent requires an intact immune system.