Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined Any uncontrolled active medical disorder that would preclude participation as outlined Any uncontrolled active medical disorder that would preclude participation Any uncontrolled medical or psychiatric disorder that would preclude participation Any uncontrolled active medical disorder that would preclude participation as outlined Any uncontrolled active medical disorder that would preclude participation Any uncontrolled active medical disorder that would preclude participation as outlined Any uncontrolled active medical disorder that would preclude participation as outlined Psychiatric disorder or social or geographic situation that would preclude study participation. Psychiatric disorder that would preclude study participation