Concurrent active second malignancy for which the subject is receiving therapy, other than non-melanomatous skin cancer or superficial transitional cell carcinoma History of another malignancy within years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low grade T tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <% at years Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted Patients must not have any other malignancies within the past years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin or active non-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial; examples include but not limited to: urothelial cancer grade Ta or T, adenocarcinoma of the prostate treated by active surveillance Prior malignancy in the past years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that has not been treated in the prior months or expected to require treatment for recurrence during the course of the study History of another primary malignancy within the last years except: \r\n* Adequately treated in situ carcinoma of the cervix\r\n* Non-melanoma carcinoma of the skin\r\n* Any other curatively treated malignancy that has not been treated in the prior months and is not expected to require treatment for recurrence during the course of the study Other active invasive malignancy. History of non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast is allowed, as is history of other invasive malignancy that is in remission after treatment with curative intent Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least years previously with no evidence of recurrence History of another malignancy within years prior to randomization except for non-melanomatous carcinoma of the skin or adequately treated, non-muscle-invasive, urothelial carcinoma of the bladder (i.e., TIS, Ta and low-grade T tumors) History of another malignancy within years prior to randomisation except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T tumours). Second primary malignancy only if treatment would interfere with the patients participation in this trial in the opinion of the treating physician; clear exceptions are ) patient had a second primary malignancy but has been treated and disease free for at least years, ) in situ carcinoma (e.g. in situ carcinoma of the cervix) and, ) additional skin cancers that have been definitively treated by surgery and/or radiation; patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as intravenous immunoglobulin [IVIG] is permitted) Second primary malignancy except most situ carcinoma (e.g. in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least years previously with no evidence of recurrence Second primary malignancy, except those second primary malignancies that are not considered to be competing causes of death in the opinion of the treating investigator; examples include: in situ carcinoma of the cervix, adequately treated non-melanoma carcinoma of the skin, or other malignancy treated at least years previously with no evidence of recurrence Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least years previously with no evidence of recurrence). Patients with a history of a second malignancy within years of the baseline visit excluding cutaneous carcinomas and in-situ carcinoma. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least years previously with no evidence of recurrence) Second primary malignancy; exceptions are ) patient had a second primary malignancy but has been treated and disease free for at least years, ) in situ carcinoma (e.g. in situ carcinoma of the cervix), ) non-melanomatous carcinoma of the skin Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or\n carcinoma in situ). Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ) Patients with a second malignancy within the last years are not allowed, except for those with non-melanomatous skin cancer and carcinoma-in-situ or the cervix; all prior invasive malignancies must be in complete remission Any concurrent or previous malignancy within years prior to randomization, except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm. Active second primary malignancy or history of second primary malignancy within the last years, with the exception of basal cell skin cancers or carcinoma in situ that have been adequately treated Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > years Participant has had any other malignancy within years prior to randomization, with the exception of adequately treated in situ carcinoma of the cervix, uterus, or nonmelanomatous skin cancer (all treatment of which should have been completed months prior to enrollment). History of another malignancy within years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T tumours). Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy completely resected with no recurrence Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated . or more years before enrollment in this study, with no subsequent evidence of recurrence Second primary malignancy; exceptions are ) patient had a second primary malignancy but has been treated and disease free for at least years, ) in situ carcinoma (e.g. in situ carcinoma of the cervix), ) non-melanomatous carcinoma of the skin Any other active malignancy. Any other previous malignancy is allowed providing that the tumor was curatively resected and there is no evidence of recurrence within months prior to enrolment to the study. In addition, adequately treated in-situ carcinoma of the cervix, uteri, or non-melanonatous skin cancer are allowed provided that all treatment was completed months prior to enrollment. another malignancy within years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancer Any other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the years prior to enrollment in this study. Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least years previously with no evidence of recurrence Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least years previously with no evidence of recurrence; prior low grade [Gleason score less than ] localized prostate cancer is allowed). Patients with another active malignancy within the past five years except for carcinoma in situ of cervix or in situ carcinoma of the bladder or non-melanomatous carcinoma of the skin Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix Prior history of any other malignancy within past three years, except melanomatous skin cancer or carcinoma in situ.