Patients must have given signed, informed consent prior to registration on study All subjects must have given signed, informed consent prior to registration on study All patients must have given signed, informed consent prior to registration on study Patients must have given written, signed and dated informed consent prior to registration on the study; NOTE: no study-specific screening procedures may be performed until consent has been given All patients must have given signed, informed consent prior to registration on study All patients must have given a signed, informed consent prior to enrollment on study All patients must have given signed, informed consent prior to registration on study All subjects must have given signed, informed consent prior to registration on study All patients must have given signed, informed consent prior to registration on study All patients must have given signed, informed consent prior to registration on study All subjects must have given signed, informed consent prior to registration on study All patients must have given signed, informed consent prior to registration on study All patients will have given signed, informed consent prior to registration All participants must have given signed, informed consent prior to registration in study All patients must have given signed, informed consent prior to registration on study All subjects must have given signed, informed consent prior to study registration Informed consent must be given and signed