he participants provided informed consent before they were aware of their group assignment and before they were assessed. Before giving their consent, patients were offered a general overview of the aims and characteristics of the study and interventions. They were informed that they would be participating voluntarily and that they could withdraw at any time, with the guarantee that they would continue to receive the treatment considered most appropriate by their doctor. Data collection involved no risk to the participants. A patient was considered to have withdrawn from the trial if he or she withdrew informed consent, the researcher felt that he or she should withdraw from the study for safety reasons, or the researcher felt it to be in the best interest of the patient.