The present study is primarily focused on the pragmatic value of a treatment strategy. Therefore, the analysis of effectiveness is primarily concerned with the treatment offer, regardless of possible deviations from the protocol. Since all participants after randomization have the opportunity to make use of the treatment offer, the intention-to-treat population in the study consists of all patients who have been notified about the result of their randomization (ICH, 1998). Consequently, the month 12 data (Figure 3: assessments [10] and [4]) of every subject in the intention-to-treat population are used for the primary research question on effectiveness, regardless of whether the patient has adhered to the protocol. Although the choice for this intention-to-treat population was considered to be strict, it was anticipated that it would yield estimates of treatment effects most similar to those in subsequent treatment practice, as well as produce the most undisputed results.