The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do. Researchers also watch closely for unexpected adverse reactions. Normal history and physical examination. Differential within institutional normal limits or approval of site physician. Negative hepatitis B surface antigen.
Normal urine dipstick with esterase and nitrite.
History of immunodeficiency, chronic illness, or autoimmune disease. History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure. History of suicide attempts within 3 years or recent suicidal ideation. History of requirement for antipsychotic medication. History of anaphylaxis or other serious adverse reactions to vaccines.