 1. In accordance to section 10, subsection 1, of the WMO, the investigator will inform the subjects and the reviewing accredited Medical Ethical Committee METC if anything occurs, on the basis of which it appears that the disadvantages of participation may be significantly greater than was foreseen in the research proposal. The study will be suspended pending further review by the accredited METC, except insofar as suspension would jeopardize the subjects health. The investigator will take care that all subjects are kept informed. 