ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the patient from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patient with serious medical of psychiatric illness likely to interfere with participation on this clinical study Participant has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patient must not have serious medical or psychiatric illness likely to interfere with participation in this clinical study in the opinion of the investigator. Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator Active, uncontrolled serious infection or medical or psychiatric illness, that in the investigators opinion is likely to interfere with participation in this clinical trial Serious medical or psychiatric illness likely to interfere with participation in this clinical study Active, uncontrolled, serious infection, or medical, or psychiatric illness likely to interfere with participation in this clinic trial Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients must not have a serious medical or psychiatric illness likely to interfere with study participation RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients must not have a serious medical or psychiatric illness likely to interfere with study participation Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious psychiatric illness or addiction likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study. No serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Participant with a serious medical or psychiatric illness likely to interfere with participation in the study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Concomitant medical or psychiatric illness that is likely to interfere with a reasonably safe execution of the treatment plan Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study per the judgment of the treating physician Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Active, uncontrolled, serious infection or medical or psychiatric illness likely to interfere with participation in this clinic trial Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study Subject has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.