Informed consent: (i) In all investigations, a freely given, informed, written consent is required to be obtained from each study subject. The investigator shall provide information about the study verbally and through the patient information sheet, in a language that is non-technical and is understandable by the study subject. The subject's consent must be obtained in writing using an 'Informed Consent Form'. The patient information sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to the Central Licensing Authority. Any change in the informed consent documents should be approved by the Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.