Use of other investigational agents from  days prior to the Screening Visit through discontinuation of study drug.
Subjects with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at the Screening Visit, the following criteria are met:
Patient has experienced a decline in ECOG performance status between Baseline visit and within  hours prior to randomization.
Patient has a > % decrease in serum albumin level between Baseline visit and within  hours prior to randomization.
Patient has a > % decrease in weight between Baseline visit and within  hours prior to randomization.
Are postmenopausal for at least  year before the screening visit, OR
Platelets >=  x ^/L, at the screening visit
Are postmenopausal for at least  year before the screening visit, OR
Creatinine (Cr) >  mg/dL at the screening visit
Hemoglobin <  g/dL at the screening visit at the screening visit
Creatinine (Cr) >  mg/dL at the screening visit
Withdrawal from the OPN-- study prior to the final EOT visit
Subjects with a platelet count of at least  x ^ at the screening visit
Are postmenopausal for at least  year before the screening visit, OR
Age ? years at the screening visit.
Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management within  weeks of the screening/enrollment visit
Are postmenopausal for at least  year before the screening visit, or
Are at least age  at screening (Visit )
Locoregional treatment within  weeks prior to the Baseline Visit.
INCLUSION CRITERIA\n\n          . Patient is ambulatory male or female  to  years of age at the Screening Visit.\n\n          . Patient has SCD, including HbSS, HbSC, HbS?-thalassemia, or HbS?+-thalassemia,\n             documented in their medical history.\n\n          . If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable\n             regimen.\n\n          . Per medical history and/or patient recall, patient has had at least  and no more than\n              sickle cell-related pain crises in the  months before the Screening Visit and\n             none occurring in the  weeks before the Randomization Visit.\n\n          . Patient completes daily eDiary entries for at least  days during the last  days of\n             the Run in Period as assessed at the Randomization Visit.\n\n          . Women of childbearing potential must have a negative pregnancy test prior to\n             randomization and must agree to use protocol-specified contraception from the\n             Screening Visit through  days after the final dose of study drug.\n\n          . Male patients must be surgically sterile by vasectomy (conducted ? days before the\n             Screening Visit or confirmed via sperm analysis) or must agree to use\n             protocol-specified contraception and agree to refrain from sperm donation from the\n             Screening Visit through  days after the final dose of study drug.\n\n        EXCLUSION CRITERIA\n\n          . Patient requires a program of prescheduled, regularly administered chronic blood\n             transfusion therapy.\n\n          . Patient has been hospitalized for an SCD-related complication in the  weeks before\n             the Randomization Visit.\n\n          . Patient has taken opioid(s) > morphine mg equivalent/day within the  weeks before\n             the Randomization Visit.\n\n          . Patient is taking aspirin ? mg daily, PY inhibitors, any anticoagulant\n             medication, specific inhibitors of phosphodiesterase  (PDE), nonspecific inhibitors\n             of PDE, moderate or strong cytochrome P A (CYPA) inhibitors, any supplements for\n             the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors\n             in any form.\n\n          . Patient has major concurrent illness or medical condition that in the opinion of the\n             Investigator would preclude participation in a clinical study.\n\n        NOTE: Other inclusion and exclusion criteria apply, per protocol
Age ? years at the screening visit.
Haematologic and biochemical indices within the ranges shown below at the screening visit
Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit ):
Group  - patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within  months prior to the Screening Visit.
For Cohort C: Has received treatment with -? reductase inhibitors (e.g., finasteride, dutasteride), estrogens, and/or cytproterone within  weeks of the screening visit
Oral, implantable or injectable contraceptives for  consecutive months before the baseline/randomization visit.
Any prostate related investigational therapy within  months of Visit 
Cryoablation should be performed within  days of screening visit
Prior radiation therapy of the index tumor < weeks prior to the screening visit
Are postmenopausal for at least  year before the screening visit, OR
Are postmenopausal for at least  year before the Screening visit , or
Exposure to other investigational products within  days prior to Screening Visit
Uncontrolled angina within  months before the Day  visit.
Subject has used any of the following within  days before the Day  visit:
Use of an investigational agent within  weeks before the screening visit;
Thromboembolism within  months of screening visit
Major surgery or radiation therapy within  days of screening visit
Are postmenopausal for at least  year before the screening visit, OR
Phase b subject has a positive drug or alcohol urine test at screening visit.
Are postmenopausal for at least  year before the screening visit, OR
Treatment with a systemic investigational agent within  days before the screening visit.
Were postmenopausal for at least  months before the screening visit, OR
The patient has pathologically documented AML and is in CR at the time of the screening visit
The patient achieved CR within  weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visit
The patient has not received an investigational chemotherapy within the last  days prior to the screening visit and has never received investigational immunotherapy. In addition, the patient must not receive treatment for AML (including treatment with IL- or IFN?) in the interval of time between the screening visit and initiation of pre-infusion preparative therapy
Enrollment within  days of the completion of End of Treatment Visit of the original study
Subject has positive test result at the screening visit for one or more of the following:
Ability to adhere to dose and visit schedules.
Completed the End of Study Visit in Study NEOD-
Progression should have occurred within the immediate prior  months of the time of screening visit, with no intervening anti-cancer therapy
The presence of TAM as per below diagnostic criteria at baseline (or screening if baseline visit is skipped). All the criteria have to be met for the patients included in the study:
Any active, severe local or systemic infection at the screening visit
All subjects must be >/=  years at the first screening examination / visit
Active bleeding within  weeks prior to screening visit
Are postmenopausal for at least  year before the screening visit, OR
Are postmenopausal for at least  year before the screening visit, OR
Has had end of trial visit in CS prior to approval of the CSA protocol.
Subjects taking immunosuppressive medications at the screening visit
Received AT treatment within the last  months prior to Screening visit.
Administration of other investigational drugs within  days preceding the screening visit, except for anticancer treatments.
Are post-menopausal for at least  year before the screening visit, OR
Are postmenopausal for at least  year before the screening visit, OR
Any active, severe local or systemic infection at the screening visit
Undergone a therapeutic surgical procedure within  days from the screening visit.
Uncontrolled angina within  months of Screening visit;
History of GI bleeding within  months of Screening visit
All subjects must be ?  years at the first screening examination / visit
Other investigational therapy received within  weeks prior to screening visit
Are postmenopausal for at least  year before the screening visit, or
At least  months was passed since the hysterectomy at time of visit 
Participated in an investigational study for radiation dermatitis within  months of the screening visit
Subjects with a platelet count of at least  x ^/L at the screening visit
Other (non-cancer) disease not stabilized within  month before the Screening Visit
Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a  month washout period from the time of the screening visit
Screening visit  must occur within  weeks prior to administration of the first dose of Polyphenon E
Positive urine drug test at screening visit
History of  or more biopsy confirmed BCCs in the preceding  years, calculated from  years prior to the screening visit; the number of BCCs found at the screening visit will not be included in the number of BCCs that qualify the subject for the study; if the subject after signing the consent form is found to not have had  BCCs prior to the screening visit then they will be a screen failure and will not enter the study
Subjects taking immunosuppressive medications at the screening visit (day )
Subject agrees to complete follow up visit
Year  visit can not exceed  years and  months from the baseline visit
Subjects agree to be contacted - weeks after each study visit
Known pregnancy at study Visit .
Presenting for colposcopy at study Visit .
Creatinine < (. mg/dL) at the screening visit
Any Parkland outpatient visit during study period
Patients must have been seen for a visit for cancer surveillance between  and 
Patients who have not undergone a visit for cancer surveillance since 
Are postmenopausal for at least  year before the Screening visit, or