1.2 Subject protection Informed consent will be obtained from all subjects to be entered in the study. In obtaining the informed consent and in the conduct of the study the principles outlined in the Declaration of Helsinki on experimentation involving human subjects should be adhered to. At each visit, the clinician will evaluate patients for any untoward effects. In case a patient requires any treatment during the course of the study, the necessary treatment will be provided at the discretion of the clinician and according to the current standard of care.