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Excessive bleeding per rectum required urgent laparotomy, which revealed frank blood in the large and small gut loops and submucosal dilated vessels of about 2 cm in the mid ileum for which bowel loop resection was done 3 cm each proximally and distally with uneventful recovery

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Also, if so, I don't think Clinuvel would be further responsible for monitoring, if the EMA accepted a generic to be applied in the centres