4. Methods and assessments: 4.1 Visit 1- screening All potential patients will be screened for eligibility at visit 1. Informed consent (ICF) will be explained to the patient prior to conducting any study procedures. A discussion in which the patient is explained about the advantage and disadvantage of the trail and the trail procedures will be taken. If participation is agreed to by the patient after they read the ICF, the patient will sign and date the ICF, and get a copy of the signed and dated form.