 14. Drug or alcohol abuse at the screening or in the past which according to the Investigator makes the patient ineligible for participation in the study: intake of more than 5 units of alcohol a week 1 unit of alcohol is equivalent to 12 liter of beer, 200 ml of vine or 50 ml of alcohol or anamnestic data on alcoholism, narcomania, drug abuse andor history of significant alcohol or drug abuse inducing drug dependence, within one year prior the screening visit. 