Strengths
Our analysis plan has several strengths. We have predefined our analysis plan and this will reduce outcome reporting bias and data-driven results. Our conclusions will be based on only one primary outcome, i.e., quality of life (measured using SF-36 physical component score) which is a patient-important outcome and is therefore of high relevance to the patients and the clinicians when choosing treatment. Our sample size estimation is based on similar studies assessing the quality of life and studies assessing minimal important differences [We have performed a sample size estimation based on previous evidence [Hence, our trial will be conducted with low risks of both random errors (“play of chance”) and systematic errors (“bias”) [