Figure 1.

Flow of Patients Through Enrollment in the 3 Randomized Clinical Trials

BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared).

^aObservational study was performed alongside randomized clinical trials; results from the observational study are not reported in this article.

^bParticipants not eligible for participation due to 1 positive exclusion criterion or more could be included in the observational study.

^cParticipants were excluded based on psychological problems, assessed by validated questionnaires.