 2. Patient information and informed consent Before being admitted to the clinical study, the patient must consent to participate after the nature, scope, and possible consequences of the clinical study have been explained in a form understandable to her. An informed consent document, in Arabic language, contains all locally required elements and specifies who informed the patient. After reading the informed consent document, the patient must give consent in writing. The patients consent must be confirmed at the time of consent by the personally dated signature of the patient and by the personally dated signature of the person conducting the informed consent discussions. If the patient is unable to read, oral presentation and explanation of the written informed consent form and information to be supplied to patients must take place in the presence of an impartial witness. Consent must be confirmed at the time of consent orally and by the personally dated signature of the patient or by a local legally recognized alternative e.g., the patients thumbprint or mark. The witness and the person conducting the informed consent discussions must also sign and personally date the consent document. The original signed consent document will be retained by the investigator. The investigator will not undertake any measures specifically required only for the clinical study until valid consent has been obtained. 