Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document and follow study procedures including willingness to undergo study biopsies Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent Ability to understand and the willingness to sign a written informed consent document that is approved by the local institutional review board Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign a written Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Informed consent: all subjects must have the ability to understand and the willingness to sign an Institutional Review Board (IRB) approved consent form Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign a written informed consent document that is approved by an institutional review board Ability to understand and the willingness to sign a written informed-consent document that is approved by the local institutional review board Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign the Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document Ability to understand and the willingness to sign a written informed consent document that is approved by the local institutional review board Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document