Active or history of autoimmune disease or immune deficiency; Active or history of autoimmune disease or immune deficiency Patients with known inborn errors of metabolism of primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency and porphyria Active, known, or suspected immunosuppressive disorders, such as acquired or congenital immune deficiency syndromes and autoimmune diseases Active or history of autoimmune disease or immune deficiency Active or history of autoimmune disease or immune deficiency Immune deficiency disease or known history of HIV, HBV, HCV Patients with a history of a metabolic disorder including documented defect in urea metabolism (including documented history of gout), carnitine deficiency (primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency), fatty acid metabolism, beta-oxidation defects, pyruvate carboxylase deficiency, mitochondrial function, porphyria, or treatment refractory nephrolithiasis EXCLUSION - TREATMENT: Known primary immune deficiency or HIV positivity Presence of any condition or concurrent requirement for treatment with agents known to result in immune deficiency. Active or history of autoimmune disease or immune deficiency; Patients with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant) Active or history of autoimmune disease or immune deficiency Active or history of autoimmune disease or immune deficiency Known selenium deficiency Significant active infection or immune deficiency (including chronic use of immunosuppressive drugs) Known history of Wilsons disease or a copper deficiency Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation , antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome Immune deficiency disease or known history of HIV, HBV, HCV Any concomitant serious physical illness other than cancer (i.e., immune deficiency disease, bleeding disorder, etc.) within year prior to dosing Patients with known urea cycle disorders (i.e.: ornithine transcarbamylase deficiency) Immuosuppressive disorders (chronic steroid therapy, acquired or congenital immune deficiency syndromes, autoimmune disease) Patients with a known immune deficiency Known diagnosis of deficiency of the interleukin- receptor antagonist (DIRA) Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation , antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse Patients with known constitutional mismatch repair deficiency syndrome (CMMR-D)/biallelic mismatch repair deficiency (bMMRD) Active or history of autoimmune disease or immune deficiency Patients with immune deficiency are excluded Active or history of autoimmune disease or immune deficiency Hereditary complement deficiency History or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia) Active or history of autoimmune disease or immune deficiency Human immune deficiency virus A known hypercoagulable disorder such as activated protein C (APC) resistance (factor V Leiden), protein S deficiency, protein C deficiency, antithrombin III deficiency, hyperhomocystinemia, dysplasminogenemia, high plasminogen activator inhibitor, dysfibrinogenemia, antiphospholipid syndrome, thrombocythemia, or dysproteinemia Pernicious anemia or other anemias due to vitamin B deficiency (due to potential masking of deficiency with leucovorin) Known procoagulant disorder including prothrombin gene mutation , antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome Patient has a history of autoimmune disorder or immune deficiency disorder History of immunosuppression, or conditions associated with congenital or acquired immune deficiency Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders; Congenital or acquired immune deficiency at increased risk of infection. Known diagnosis of pituitary hormone deficiency Patients with known risk factors for thromboembolism (e.g. Factor V Leiden mutation, antithrombin III (ATIII) deficiency, Protein C and S deficiency, antiphospholipid syndrome, portal hypertension, etc.) Known deficiency in carnitine (genetic, etc.) Immune deficiency disease or known history of HIV, HBV, HCV Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive therapy that might interfere with appropriate immune response Known or documented bleeding disorders not limited to: anti-phospholipid syndrome, homozygotes for Factor V Leiden deficiency, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, systemic lupus erythematous, or prothrombin G gene mutation History of B deficiency Active or history of autoimmune disease or immune deficiency Autoimmune diseases or immune deficiency disease Any concomitant serious physical illness other than cancer (e.g., immune deficiency disease, bleeding disorder, etc.) within year prior to dosing. No history of autoimmune disease.