Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the Unites States of America [USA] only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations. Written informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluations Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject/legal representative prior to performing any protocol-related procedures Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations The patient/legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States of America [USA]; European Union Data Privacy Directive in the European Union [EU]) before any study-specific procedures, including screening evaluations, sampling, and analyses Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent must be obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of American [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Information Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g.,) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study; written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA]) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations Written informed consent by the patient (or legal representative) prior to admission to this study. In addition any locally required authorization (Health Insurance Portability and Accountability Act in the USA [HIPAA], obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. Written informed consent and any locally required authorization (eg, HIPAA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. Written informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluations Written informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations