Patient must provide study-specific informed consent prior to study entryXx_NEWLINE_xXPatient must be able to provide study-specific informed consent prior to study entryXx_NEWLINE_xXPatient must be able to provide study specific informed consent prior to study entryXx_NEWLINE_xXPatient must provide study specific informed consent prior to study entryXx_NEWLINE_xXPatient must be able to provide study-specific informed consent prior to study entryXx_NEWLINE_xXThe 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 timeXx_NEWLINE_xXPatient must provide study-specific informed consent prior to study entryXx_NEWLINE_xXPatient must provide study specific informed consent prior to study entryXx_NEWLINE_xXPatient must provide study specific informed consent prior to study entryXx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent prior to study entryXx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent prior to study entryXx_NEWLINE_xXPatient must have provided study specific informed consent prior to study entryXx_NEWLINE_xXPatient must provide study specific informed consent prior to study entryXx_NEWLINE_xXPatients must sign a study-specific informed consent prior to study entryXx_NEWLINE_xXThe patient must provide study-specific informed consent prior to study entryXx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent prior to study entry.Xx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent prior to study entryXx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent prior to study entryXx_NEWLINE_xX