Patient must provide study-specific informed consent prior to study entry Patient must be able to provide study-specific informed consent prior to study entry Patient must be able to provide study specific informed consent prior to study entry Patient must provide study specific informed consent prior to study entry Patient must be able to provide study-specific informed consent prior to study entry The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time Patient must provide study-specific informed consent prior to study entry Patient must provide study specific informed consent prior to study entry Patient must provide study specific informed consent prior to study entry The patient or a legally authorized representative must provide study-specific informed consent prior to study entry The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Patient must have provided study specific informed consent prior to study entry Patient must provide study specific informed consent prior to study entry Patients must sign a study-specific informed consent prior to study entry The patient must provide study-specific informed consent prior to study entry The patient or a legally authorized representative must provide study-specific informed consent prior to study entry. The patient or a legally authorized representative must provide study-specific informed consent prior to study entry The patient or a legally authorized representative must provide study-specific informed consent prior to study entry