 E.3.3. Randomization: the study will be double blinded study and the randomization will be conducted by the hospital pharmacist whom will be responsible of dispensing the medication to the patients after coding it with a special code related to the patient ID and the records is kept with the pharmacist till the end of the study. Physicians and other caregivers will be blinded as to who is receiving placebo or study drug. Only the pharmacist at the Investigational Drug Service or similar service will be aware of the assignment. Each patient will receive a study number which will identify the patient. The number will allow for confidentiality while simultaneously allowing patient identification by the principal investigator at each center if it should it be necessary. 