Any psychiatric condition that would prohibit the understanding or rendering of informed consent. Dementia or altered mental status that would preclude understanding and rendering of informed consent Dementia or altered mental status that would preclude understanding and rendering of informed consent Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements. Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patients study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements. Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patients study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements Any psychiatric condition that would prohibit the understanding or rendering of informed consent Any psychiatric condition that would prohibit the understanding or rendering of informed consent Any psychiatric condition that would prohibit the understanding or rendering of informed consent Any psychiatric condition that would prohibit the understanding or rendering of informed consent Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements Any psychiatric condition that would prohibit the understanding or rendering of informed consent Patient has dementia or altered mental status that would prohibit the understanding or rendering of informed consent. Any psychiatric condition that would prohibit the understanding or rendering of informed consent Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent Any psychiatric condition that would prohibit understanding or rendering of informed consent. Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Dementia, altered mental status, or any other medical condition or disorder that would prohibit the understanding or rendering of assent (if applicable), or ability to comply with study procedures. Any psychiatric condition that would prohibit the understanding or rendering of informed consent Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent Any condition that would prohibit the understanding or rendering of informed consent