<qa>  What is the inclusion procedure that implies that all relevant patients in Norway will be offered participation?The inclusion procedure implies that all relevant patients in Norway in the given time period will be offered participation. If this population turns out to be fewer than 160 patients during the study period, the inclusion period might be extended six months. If less than 160 patients are included at that point, analyses will be performed on the number of patients included by the end of the study period. 