Trial design
This study was a long-term follow-up of a previous randomized controlled trial. The trial design was a prospective, parallel-group, randomized (1:1 ratio) controlled trial. The trial was approved by the Regional Ethics Committee of Northern Ostrobothnia Hospital District (EETTMK: 46/2003) and health care centre supervisors. The trial is registered at ClinicalTrials.gov (NCT02010346). There were no changes in the methods after trial commencement. No harms were observed during this study. The protocol was not published before the screening. Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines were followed [