All adverse events encountered during the study period will be reported on the case record forms. The subjects will be urged to report any adverse events immetiately after appearance. All adverse events will be grated on a scale form 1 to 3, where 1 = mild, 2 = moderate and 3 = severe. The investigator will also be requested to judge the causality of each adverse event to the treatment (1 = not related, 2 = possibly related and 3 = probably related). If serious adverse effects occurs the sponsor shall be notified within 24 h by telephone and subsequently in writing by the investigator. All serious adverse events must be reported to national regulatory authorities within 24 hours of occurence.