Patient must sign study specific informed consent prior to study entry Patients must sign a study-specific informed consent prior to study entry All patients must sign study specific informed consent prior to study entry Patient must sign study specific informed consent prior to study entry Patients must sign a study-specific informed consent form prior to study entry Patients must sign a study-specific informed consent form prior to study entry; patients should have the ability to understand and the willingness to sign a written informed consent document All patients must sign study specific informed consent prior to study entry or within week of first treatment, provided other criteria were met Ability to understand and willingness to sign a study-specific informed consent prior to study entry Patient must sign study specific informed consent prior to study entry Subject must sign a study specific informed consent prior to study entry Patients must sign informed consent prior to study entry Patient is able to give and sign study specific informed consent Patients must give study specific informed consent prior to enrollment Patient must sign study specific informed consent prior to study entry Subjects must understand and sign the study specific informed consent Patients must sign study specific informed consent Patients must sign a study-specific informed consent prior to study entry Patients must sign study specific informed consent prior to study entry Patients must sign a study-specific informed consent form prior to study entry; patients should have the ability to understand and the willingness to sign a written informed consent document Subject must understand and sign the study specific informed consent Patients must sign informed consent prior to study entry Patient is willing to sign study specific informed consent Patients must sign a study-specific informed consent form prior to study entry The patient must sign specific informed consent prior to study entry Patient is able to give and sign study specific informed consent Subject must sign a study specific informed consent prior to study entry Patients must sign a study-specific informed consent prior to study entry Patient must sign study-specific informed consent prior to study entry Patient must sign study-specific informed consent prior to study entry Subject must sign a study specific informed consent prior to study entry The patient must have capacity to be able to sign a study-specific informed consent prior to study entry