- Evidence of any of the following conditions per subject self-report or medical chart review: Any prior invasive malignancy within 5 years before randomization/ Any non-invasive malignancy not treated with curative intent or with knownactive disease within 5 years before randomization/ Major surgery or significant traumatic injury occurring within 4 weeks before randomization/ Active infection with Hepatitis B virus or Hepatitis C virus/ Known infection with human immunodeficiency virus (HIV)/ Active infection requiring IV anti-infective therapy