Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol Significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason. Significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason. Significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason. Dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Subjects with dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol, or psychiatric illness/social situations that would limit compliance with study requirements Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol. Dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol