Ethics and dissemination

This trial will be conducted according to the Helsinki Declaration. The protocol has been approved by the institutional review board of the Helsinki and Uusimaa Hospital District (approved on 14 May 2012, Dnro 118/13/03/02/2012), and the trial has been duly registered at ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT01719887","term_id":"NCT01719887"}}NCT01719887).

All modifications of the study protocol will be communicated by updating the trial registry (ClinicalTrials.gov).

The informed consent will be obtained by the recruiting doctor at the participating centre. The consent form is written either in Finnish or Swedish and the patient can choose which one to use. The consent forms are supplied as online supplementary files (supplementary materials 1 and 2). Consent will also be obtained from patients belonging to the declined cohort and the non-eligible cohort.

Both participant data forms and electronic databases will be maintained in secure storage at the coordinating centre for 10 years after completion of the study (after the last patient has reached the 10-year follow-up point).

The research nurse in the participant centre is the only person who has access to the electronic trial data during the data collection. After the final data set is formed from the primary data, data set access will be limited to statisticians and the authors of the final publication. The codes of the RCT arms will be known only to the research nurse until the blinded data interpretation has taken place.

Patients will be treated during and after the trial with the best intention. In addition to the planned follow-up visits, patients will receive additional physiotherapy and other interventions at the discretion of the treating doctor. Participating patients will not receive any compensation from the harms of the treatment beyond the compensation from the Finnish Patient Insurance Centre if malpractice has taken place.

The findings of this study will be disseminated through peer-reviewed publications and conference presentations. Patients participating in the trial will be sent a letter with information on the results after the primary outcome results are published.