A total of six cardiovascular events occurred in the intervention group, and eight occurred in the control group. No events were deemed to be probably or definitely study-related. At data-collection visits, 18.3% of the participants in the intervention group and 13.0% of those in the control group reported a medical hospitalization, and 14.8% of the participants in the intervention group and 20.6% of those in the control group reported a psychiatric hospitalization.