Patients with secondary APL are excluded; this includes all patients with APL that may have resulted from prior treatment (chemotherapy or radiation) Patients will be excluded from this study if they are found to harbor favorable risk cytogenetics Patients with a rhabdomyosarcoma will be excluded Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study Patients with secondary malignant gliomas will be eligible for this study but should conform to all other eligibility requirements; patients with low-grade gliomas are excluded Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry Patients lacking the capacity to describe their symptoms are excluded Patients will not be excluded on the basis of sex, racial or ethnic background No congenital or acquired immune deficiency. These patients are excluded due to the expected intense immunosuppression, increased risk of opportunistic infections, and higher expected septic death rate in this subgroup of patients with this proposed therapy. Pancreatic neuroendocrine tumors (islet cell carcinoma) will be excluded from this study; all non functional and functional islet cell carcinomas such as insulinoma, glucagonoma, gastrinoma, vasoactive intestinal peptide (VIP)oma will be excluded Patients using over the counter supplements or other natural products within one week of treatment, excluding vitamins and calcium supplementation, or at the discretion of the enrolling physician, will be excluded Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded unless otherwise approved by the PI or PIs designee Patients with anemia (hemoglobin [HEM] < g/dl) at baseline will be excluded unless otherwise approved by the PI or PIs designee Patients with salivary gland tumors are excluded (patients with nasopharynx CA or sinonasal cancers can participate) Patients whose tumour samples have targetable alterations in EGFR and/or ALK are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS, BRAF, MET or RET, are to be excluded. A histologic diagnosis of salivary duct carcinoma (other subtypes of salivary gland cancer are excluded). Pregnant women are excluded from this study because the effects of -OHT gel on the developing human fetus at the recommended dose and route are unknown. Women with only synthetic D mammograms generated from D (tomosynthesis) are excluded as breast density measurements are not yet validated for synthetic mammograms. Women with combination D+D mammograms are not excluded. Patients may not have any clinically significant cardiovascular disease including the following:\r\n* Myocardial infarction or ventricular tachyarrhythmia within months\r\n* Major conduction abnormality (unless a cardiac pacemaker is present)\r\n* Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out corrected QT (QTc) prolongation; the patient may be referred to a cardiologist at the discretion of the principal investigator; patients with underlying cardiopulmonary dysfunction should be excluded from the study Patients with subependymal giant cell astrocytomas are excluded; patients with intrinsic brain stem tumors of the pons will be excluded from the study All patients with known diagnosis of neurofibromatosis type or other known retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS)-opathies are excluded Patients allergic to sesame seed oil or cottonseed oil are excluded Treatment with colchicine is excluded. Platelets >= ,/uL; a subject will not be excluded because of pancytopenia related to disease Patients with any disease that will obscure toxicity or dangerously alter drug metabolism are excluded Patients with previously documented macular degeneration or diabetic retinopathy are excluded from the trial Patients with Charcot-Marie-Tooth disease or other demyelinating diseases are excluded from the liposomal vincristine containing arm Patients experiencing more than watery bowel movements per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection are excluded Tumors harboring non-hotspot POLE or POLD mutations that show clear evidence of microsatellite instability (MSI) will be excluded Currently with an active acute infection, or suspected infection, a single oral temperature of ? F or a temperature of ? .F sustained over a h period in past h. Subjects on prophylactic antibiotics are not excluded from study Other medications:\r\n* Patients receiving other anti-neoplastic agents are excluded\r\n* Patients on enzyme-inducing anticonvulsive agents are excluded\r\n* Patients requiring strong CYPA or PGP inducers or inhibitors are excluded\r\n* Patients requiring anticoagulation or with uncontrolled bleeding are excluded\r\n* Patients on steroids for symptom management must be on a stable dose for days prior to start of treatment Patients with previously documented macular degeneration or diabetic retinopathy are excluded Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with reduced intensity conditioning (RIC) have the significant potential for teratogenic or abortifacient effects Patients with biliary obstruction or biliary stent are excluded Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction Patients with prior known toxicity from IL-A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM containing arms of the study. Subjects with any of the following conditions are excluded: Patients with second malignancy within years of enrollment; patients curatively treated non-melanoma skin cancers or carcinoma in situ of the bladder, are not excluded; patients with multiple endocrine neoplasia (MEN) and a history of pheochromocytoma will also not be excluded; in addition patients with prostate cancer who do not require systemic therapy will not be excluded; (a secondary, minor pathologic focus of another form of thyroid cancer may be coincidentally found in -% of patients with medullary thyroid cancer; in such cases, eligibility is based on the discretion of the investigator) Patients with known diabetes whose glucose control or general health condition may be adversely affected by the use of metformin as per the study protocol as deemed by either the study investigator or endocrinologist are excluded Patients with active inflammatory processes including T max > or active tissue inflammation are excluded up to and including the day of admission Pregnancy status will be obtained at time of consent as is routine for all radiation patients; pregnant women are excluded from this study Grade or higher colitis attributable to PD blockade; note that colitis attributable to ipilimumab is not excluded Patients with TI mutation will not be excluded, but their response will be analyzed separately. Patients are excluded if they have liver tumor volume > % Patients are excluded if they have a history of prior treatment with ipilimumab or CTLA- inhibitor. Patients are excluded if they have had prior hepatic arterial embolization therapy Has a known or suspected carcinoma that is excluded as administration of Oral Contraceptive would be contraindicated. Patients tumor must be deemed resectable by the study team prior to registration; borderline resectable patients will be excluded Subjects with plastic biliary stents will be excluded; metal biliary stents are allowed and will not be excluded Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study Patients with TI mutations will be excluded (this criteria is not applicable for the frontline Ph+ ALL or CML-LBC cohort) Breakpoint cluster region-Abelson positive (BCR-ABL +) patients will be excluded from the study Unreliable for follow-up (drug use, planning to move out of region ,etc.); any patient that lives more than miles away will be excluded Pregnant women are excluded from this study because propranolol is an agent with the potential for teratogenic or abortifacient effects Patients with worsening depression that has not been addressed clinically will be excluded from this study Patients with previously documented macular degeneration or diabetic retinopathy are excluded Patients with primary ampullary, biliary or duodenal cancer would be excluded Brainstem location is excluded from this study Patients will not be excluded on the basis of sex, racial or ethnic background Patients who are unable to receive MRIs will be excluded from the study Patients with the following histologies are excluded: melanoma, other soft tissue or bony sarcomas, giant cell tumor, aneurismal bone cyst or metastatic lesions from other histologies Patients with hepatocellular carcinoma will be excluded from this study Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study Patients will not be excluded on the basis of sex, racial or ethnic background Unexplained rise of CEA (i.e. smoker with elevated CEA will not be excluded) Subjects with uncontrolled, systematic infection should be excluded REGISTRATION TO TREATMENT (STEP ): No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation REGISTRATION TO TREATMENT (STEP ): No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation Patients who can only receive pentamidine therapy for PCP prophylaxis are excluded, since this drug prolongs the QT interval Pregnant women are excluded from this study because ionizing radiation is a known teratogen, and temozolomide is a class D agent with the potential for teratogenic or abortifacient effects. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded. Concomitant use of the Optune device will also be excluded. Patients with tumors that score negative in the in vitro organoid bio-assay will be excluded Patients with Li Fraumeni syndrome are excluded from the study Women of childbearing potential only: negative serum pregnancy test done =< days prior to registration; NOTE: female subjects who are pregnant or nursing are excluded from this study; there is no specific mitigation strategy for vismodegib toxicity; however, male patients should be made aware of it during the consent process; although this effect is expected to be reversible with discontinuation of dosing, long-term effects on male fertility cannot be excluded at this time Serious comorbidities (as determined by the investigator) such as, but not limited\n to, active congestive heart failure or recent myocardial infarction. Patients who\n require antifolate therapy for the management of comorbid conditions (e.g.,\n rheumatoid arthritis) will be excluded from the trial. NOTE: Patients who would be excluded from treatment on this protocol strictly for laboratory abnormalities can be included at the principal investigators discretion after consultation with the membership of the Texas Children's Cancer Center (TXCCC) Lymphoma Team Patients with lymphomas are excluded Serum total bilirubin < mg/dl; patients with Gilberts syndrome are excluded from the requirement of a normal bilirubin and patients will not be excluded if liver enzyme elevation is due to tumor involvement; NOTE: adult values will be used for calculating hepatic toxicity and determining eligibility, as is standard on Pediatric Oncology Branch (POB) phase I trials Patients with second malignancy within years of enrollment; patients treated surgically with a curative intent, such as non-melanoma skin cancers, localized kidney cancer or carcinoma in situ of the bladder, are not excluded; patients with multiple endocrine neoplasia type (MEN) and a history of pheochromocytoma will also not be excluded; in addition patients with prostate cancer who do not require systemic therapy will not be excluded; (a secondary, minority pathologic focus of another form of thyroid cancer may be coincidentally found in -% of patients with medullary thyroid cancer; in such cases, eligibility is based on the discretion of the investigator) Patients who have received ipilimumab in the past are excluded Patients may be excluded at the discretion of the PI/LAI if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk Patients with T disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded Patients will not be excluded on the basis of sex, racial or ethnic background Use of IUDs are excluded due to increased risks of infection and bleeding in this population. However, IUD inserted prior to consent may remain in place, and a second method of contraception is mandated Patients with known diagnoses that are associated with germline DDR defects such as Li Fraumeni syndrome and ataxia telangiectasia are excluded from the study Patients with adenocarcinoma of unknown primary are excluded Patients with neuroendocrine neoplasms will be excluded. EXCLUSION FOR TREATMENT: Patients will be excluded if they have isolated extra-medullary relapse of ALL Participants with adenocarcinoma of the esophagus are excluded. Pregnant women are excluded from this study because nivolumab, personalized neoantigen peptides, and Poly-ICLC are agents with unknown risks to the developing fetus. Has neutropenia (IBD and steroid use not excluded) Subjects actively receiving duvelisib are to be excluded from this study if they have any ongoing ? Grade AE considered related to duvelisib treatment at screening Patients with electronic pacemakers or defibrillators are excluded from this study, as the effect of electroporation on these devices is unknown; patients with lower extremity lesions may be discussed with the medical monitor Non-soft tissue sarcomas, such as osteosarcoma and chondrosarcoma are excluded Patients with history of erosive esophagitis should be excluded from the study No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation Warfarin use is excluded; other anticoagulants are permitted, but for participants enrolled in the RPD cohort, the investigator must deem it safe to temporarily hold to facilitate pre and on-treatment tumor biopsies; participants where this is not feasible are excluded from participation Patients with active inflammatory processes including T max > or active tissue inflammation are excluded Patients will be excluded if they are not planning to receive concurrent temozolomide Patients with gliomatosis will be excluded Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded Patients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease (IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study. Any patient with an allo-transplant of any kind would be excluded as well. This would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration. Mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded. Patients must not have diagnosis of agammaglobulinemia; patients with the following will be excluded:\r\n* Undetectable anti-tetanus toxoid IgG (except for retreatment)\r\n* Known history of agammaglobulinemia East Asian patients (Chinese, Japanese, Taiwanese, and Korean ancestry) are excluded during stage I of the study (dose escalation phase) CML CP patients are excluded if they are in Complete cytogenetic response (CCyR) Patients who are HIV+ will be excluded For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry. Pediatric patients (younger than years) will be excluded. Patients with radiographic or cytologic evidence of leptomeningeal or multicentric disease will be excluded and replaced if needed Each patient will have undergone definitive resection to be eligible for enrollment; this will be followed by standard of care conformal external beam RT with concurrent TMZ; patients are not permitted to have had any other conventional therapeutic intervention other than steroids, or current radiation or TMZ therapy prior to enrollment (TMZ must have been administered > months before enrollment); patients who receive previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies will be excluded and replaced if needed; patients who received immunosuppressive therapy for an autoimmune disorder or an organ transplant and/or require prolonged steroid therapy (> days) will be excluded Patients who have a programmable shunt will not be excluded Patients with brain metastasis that are unstable (i.e. presenting with neurologic symptoms that progress or require increasing doses of steroids within a -week period) or are untreated (i.e. not radiated) should be excluded Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation; the patient may be referred to a cardiologist at the discretion of the treating physician; patients with underlying cardiopulmonary dysfunction should be excluded from the study Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or rectosigmoid cancer neoplasms and IBD are excluded. Patients will be excluded if they have had any positive fungal culture in the last days prior to enrollment. Patients with electronic pacemakers or defibrillators are excluded. Subjects with known q MLL rearrangement are excluded. Subject has confirmed cholestatic hyperbilirubenemia due to bile duct obstruction. Subjects who have liver dysfunction due to metastasis alone are excluded. Patients with implantable or wearable electrical devices will be excluded from this study Pregnant women are excluded to avoid the risk of systemic intrauterine/neonatal HSV infection Prior treatment with capecitabine and/or celecoxib is allowed; however, patients with a documented history (at the time of enrollment) of >= grade toxicities with capecitabine or celecoxib are excluded Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded - Adult patients with histologic verification of carcinoma of the pancreas (T-, N-)\n who have undergone surgical resection within the past - weeks. Patients with R\n resections are excluded.\n\n - Must meet all laboratory safety criteria and not have active or history of autoimmune\n disease or conditions, be treated with immunosuppressive drugs, or require the use of\n systemic steroids. Primary intraoperative chemotherapy will be allowed.\n\n - Pregnant or nursing women will be excluded. Subjects with active infection, HIV,\n Hepatitis B or C will be excluded. AKT INHIBITOR MK ARM: Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial Patients on digoxin will be excluded from this study Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; NOTE: patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy) would be excluded, as they would not need systemic chemotherapy Participants of North/East Asian ethnicity (ie, Japanese, Chinese, Korean) will be excluded. Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial Pregnant women and breast feeding women are excluded from this study because of the risk to a fetus due to docetaxel chemotherapy and OGX- systemic treatment (fertility toxicology studies have not been completed for OGX-). Patients with the following manifestations of cardiovascular disease are excluded: Patients with electronic pacemakers or defibrillators are excluded from this study Because of compromised cellular immunity and limited capacity to respond to vaccination, patients who are human immunodeficiency virus (HIV)+ will be excluded Patients with a history of clinically significant venous thromboembolism will be excluded on cohort ; patients with tumor associated thrombus in the renal vein will not be excluded All patients must have histological evidence of a solid malignant tumor (hematological malignancies are excluded) with convincing clinical, radiographic or isotopic evidence of cancer, for which no effective proven treatment exists. CNS associated tumors are preferred, but not required. Patients must sign an informed consent that complies with the investigator/DEKK-TEC policies and approved by a Human Investigation Review Committee. Patients that start chemotherapy or radiotherapy during the study time ( month post diagnostic bronchoscopy), will be excluded from the study Patients with active infections, including HIV, will be excluded, due to unknown effects DAC/THU on systemic immunity Patients with documented central nervous system (CNS) ischemia and/or infarction, whether symptomatic or discovered incidentally without clinical symptoms, will be excluded from study participation Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study) Participants with certain cardiovascular conditions are excluded. Men are excluded from this study Participants with any of the following cardiovascular conditions are excluded: Excluded patients will be allowed to participate in the trial on an observational basis only Patients with currently uncontrolled cardiac arrhythmias (non-sinus rhythm) will be excluded; patients with history of arrhythmias under pharmacological/pacemaker control will be allowed, except if receiving antiarrhythmic medication listed in contra-indicated medications below Subjects will be excluded if they do not attend pre-operative clinic dedicated to RC subjects. Subjects with galactosemia will be excluded. Patients who are currently actively tracking their steps using wearable technology or smartphone apps will also be excluded Cirrhotic patients; when incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study Antidepressant users who have been medicated for at least three months will not be excluded Patients will not be excluded on the basis of sex, racial or ethnic background Patients who are allergic to or not tolerant of EMLA cream, propofol, or fentanyl will be excluded Patients having their LPs done by students will be excluded Patients who are admitted for observation for < hours will be excluded from the study, as one day would be difficult to provide the necessary information BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes Any patients that are transferred to another unit prior to discharge will be excluded Patients will be excluded if they are hospitalized Any patient with a known or suspected inherited predisposition to cancer should be discussed with the study team prior to screening for eligibility\r\n* Patients with a known inherited or constitutional predisposition to transplant morbidities, including, but not limited to Fanconi anemia, Dyskeratosis Congenita, Shwachman-Diamond syndrome and Down syndrome will be excluded\r\n* Patients with known inherited or constitutional predisposition to non-hematologic cancers including, but not limited to Li-Fraumeni syndrome, BRCA and BRCA mutations will be excluded\r\n* Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to transplant morbidities or non-hematologic cancers will not be excluded Patients who are blind are excluded Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs) Individuals who lack the capacity to consent will be excluded from this study Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded Patients fewer than year out from completion of radiation therapy will be excluded Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded Individuals with co-morbid acute or untreated psychiatric symptoms (e.g., psychosis) or neurologic dysfunction will be excluded Patients previously enrolled, but excluded as no stent lumen obstruction from mucus retention identified at earlier enrollment (hence excluded at that enrollment) At least month from any major surgery to start of intervention, including colostomy reversal (Port-A-Cath removal excluded) Transferrin saturation < % and ferritin < ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable). Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the months preceding the Benchmark Survey Study will be excluded Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded Males will be excluded. Adults over the age of will generally be excluded from the study; older subjects could be included at the discretion of the PI Excluded patients will be allowed to participate in the trial on an observational basis only All others will be excluded Participants with a core biopsy diagnosis of atypia with associated malignancy (in the same quadrant) will be excluded. Pregnant women are excluded from this study because CESM uses radiation with the potential for teratogenic or abortifacient effects. This will be defined by a urine pregnancy test prior to the CESM study. Patients with underlying dementia (or on medications to treat Alzheimers disease such as donepezil, rivastigmine, galantamine, tacrine, or memantine), encephalopathy, or other neurological disorder known to adversely affect cognition (such as epilepsy or prior stroke) are excluded; (patients with depression or anxiety are not excluded) Men with current anal disease diagnosed by a doctor (e.g., condyloma, hemorrhoids, fissures or malignant tumors) will be excluded Women actively undergoing in-vitro fertilization or fertility treatments are excluded Pregnant women are naturally excluded given condition of cisplatin therapy Subjects demonstrating markedly inappropriate affect or behavior will be excluded from the study Men are excluded from this study Pregnant women are excluded from this research; the male partner should use a condom; Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigators discretion after approval by the Center for Cell and Gene Therapy (CCGT) Protocol Review Committee and the Food and Drug Administration (FDA) reviewer Minors will be excluded Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information or uniquely benefit from the study Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes Prisoners and members of other vulnerable populations will be excluded from this study; the subject selection population will not regularly include prisoners and other vulnerable population members as these populations will not provide any additional unique information to or uniquely benefit from the study; non-English speaking population will be excluded from the study Prisoners and members of other vulnerable populations will be excluded from this study; non-English speaking population will be excluded from the study Minors will be excluded Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from the study Patients with known active advanced malignant solid tumors are excluded (except for basal or squamous skin cancers, or carcinomas in situ); patients with additional hematologic malignancies that require treatment are excluded Patients are to be excluded from the study if they have any of the following: Patients with indications that limit or extend initial surgery, including need for lymphadenopathy, recurrent laryngeal nerve (RLN) dysfunction, and concurrent primary hyperparathyroidism will be excluded. Patients with history of known defects in fat metabolism (ie pyruvate carboxylase deficiency, prophyria, fatty acid oxidation defects, primary carnitine deficiencies, organic acidurias, hypoglicemia) will be excluded Subjects will be screened and excluded per standard clinical protocol