Sample size and analysis plan.
(DOCX)Click here for additional data file.Our group wishes to thank all the patients who participated in this trial. Moreover, this trial could not have been carried out without our oranizations and the personnel and residents of our clinics who participated treatment of the study patients. The group would like to offer our thanks to our research coordinators Seija Rautiainen and Meri Järvinen. Finally, we thank Peter Heath BA, MA for the excellent language editing.