Psychiatric disorder or altered mental status precluding informed consent or protocol-related testing Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent or limit compliance with study requirements Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures Subject has a psychiatric disorder, altered mental status or social situation that would preclude understanding of the informed consent process and/or limit compliance with study requirements Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures Psychiatric disorder or altered mental status precluding informed consent or protocol-related testing Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies. Subject has psychiatric disorder or altered mental status that would preclude an understanding of the informed consent process and/or completion of the necessary study procedures. Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies. Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies Psychiatric disorder, altered mental status precluding informed consent or necessary testing