Patients with a known hypersensitivity to the combination/comparator agent Patients with a known hypersensitivity to the combination/comparator agent History of hypersensitivity to IP or comparator agents History of hypersensitivity to the combination or comparator agent (if applicable) History of hypersensitivity to the combination or comparator agent History of hypersensitivity to the combination or comparator agent History of hypersensitivity to the combination or comparator agent (If applicable) Prior therapy with all choices of active comparator History of hypersensitivity to the combination or comparator agent Candidate for at least one comparator drug: Subjects must be candidates for at least one of the designated comparator drugs Subjects with contraindications to all of the designated comparator drugs