Signed written informed consent obtained prior to performing any study procedure, including pre-screening and screening procedures. Signed informed consent prior to any procedures Signed informed consent obtained prior to any screening procedures Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Patient has signed the informed consent prior to any screening procedures being performed and is able to comply with the protocol requirements Signed informed consent obtained prior to any screening procedures Ability to understand and the willingness to sign a written informed consent document; subject has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Signed informed consent obtained prior to any screening procedures Signed informed consent obtained prior to any screening procedures Signed informed consent obtained prior to any screening procedures Signed informed consent obtained prior to any screening procedures Ability to understand and the willingness to sign a written informed consent document; subject has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Patient has signed the informed consent form prior to the performance of any screening procedures and is able to comply with protocol requirements. Patient has signed the Informed Consent Form (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Subjects must provide a signed informed consent before any screening procedures Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirement Signed informed consent obtained prior to any screening procedures Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements. Signed written informed consent obtained prior to performing any study procedure, including screening procedures. Signed informed consent obtained prior to any screening procedures Signed informed consent obtained prior to any screening procedure