The patient has elective or planned major surgery to be performed during the course of the clinical trial Elective or planned major surgery to be performed during the course of the trial Patients with elective or planned major surgery to be performed during the course of the clinical trial The patient has elective or planned major surgery to be performed during the course of the clinical trial The patient has elective or planned major surgery to be performed during the course of the clinical trial The patient has elective or planned major surgery to be performed during the course of the clinical trial The patient has undergone major surgery within days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within days prior to first dose of protocol therapy; the patient has elective or planned major surgery to be performed during the course of the clinical trial Elective or planned major surgery to be performed during the course of the trial Patients who have elective or planned major surgery to be performed during the course of the clinical trial; minor surgery/subcutaneous venous access device placement within days prior to first dose of protocol therapy is permitted Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within days prior to enrollment. have an elective or a planned major surgery during the course of the trial Elective or a planned major surgery while on study treatment Has an elective or planned major surgery to be performed during the course of the trial Elective or a planned major surgery