Participants who consent to participate in the ASAC trial are randomly assigned by a computer to take either ASA 160 mg or a placebo, which they will take once a day for up to three years or till disease recurrence. The start of treatment is usually four weeks after surgery. All participants have 50% chance of receiving ASA. In case of medical emergency, all doctors at Department of HPB surgery at Oslo University Hospital can find out which treatment a participant is taking. This is known as unblinding. Almost all clinical scenarios can be managed by assuming a trial participant is taking ASA 160 mg once a day and withholding the trial medication. We only expect unblinding to be necessary in rare clinical circumstances where knowledge of treatment allocation is essential to guide clinical management. In case of emergency unblinding, please contact:
Oslo University Hospital, Tel: +47-23070000 or Study Nurses: Victoria Bringsjord (vicbri@ous-hf.no) or Gyda G Christiansen (gydchr@ous-hf.no)
UNBLINDING CAN ONLY BE PERFORMED BY AN HPB-SURGEON ON CALL AT OSLO UNIVERSITY HOSPITAL AND SHOULD ONLY BE CONSIDERED WHERE KNOWLEDGE OF TREATMENT ALLOCATION IS ESSENTIAL TO GUIDE CLINICAL MANAGEMENT.