 34. Subjects with acute, unstable, or untreated significant medical conditions. Subjects requiring treatment for renal impairment or other chronic disease eg, well-controlled diabetes, hypertension must be on a stable treatment plan medicines, doses, and regimens for at least 2 weeks except insulin prior to Day 1 and during the entire study. Small adjustments in the dosages of some concomitant medications may be permitted during the study, and will be discussed on a case-by-case basis. In all cases, the subjects treatment history must be reviewed and their enrollment must be agreed to by both the investigator and the sponsors medical monitor 