14. Blood donation: 0-49 ml - 0 days prior to Visit 1 (screening); 50-449 ml - in less than 30 days prior to Visit 1; 450-800 ml or more - less than 60 days prior to Visit 1; 800 ml - by the decision of the Chief Investigator, if the period of time prior to the visit 1 is more than 60 days;