Handling of missing data
Missing data will be handled according to the recommendations proposed by Jakobsen and colleagues [If necessary, we will perform a best-worst- and a worst-best-case scenario. These two scenarios demonstrate the maximum potential impact of missing data. When assessing continuous data, a “beneficial” outcome will be defined as plus two SDs of the group mean, and a “harmful” outcome defined as minus two SDs of the group mean, both “beneficial” and “harmful” outcomes being fixed imputations [When assessing dichotomous data, it will in a best-worst case scenario be assumed that all the participants lost to follow-up in the lenient intervention arm have had a “beneficial” outcome and all the participants lost to follow-up in the strict intervention arm have had a “harmful” outcome [