Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent. Any serious medical condition, laboratory abnormality, or psychiatric illness that would – in the opinion of the investigator – prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious psychological condition or psychiatric illness that would prevent the subject from signing the informed consent document, in the investigator opinion Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Patients who have any serious condition, laboratory abnormality, or psychiatric illness that would prevent them from singing the informed consent form are NOT eligible for participation Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent Patients must not have any serious medical condition or any other unstable medical co-morbidity, or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent Any serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Patient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any medical condition, that would prevent the subject from signing the informed consent form. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consent Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent Any serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent form Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form