The following ancillary studies were performed in all patients:

• Pharmacogenetics and population pharmacokinetics study
• Viral sub-type study
• Renal function study
• Quality of Life study
• Adherence study
• Pharmaco-economics study (Italy only)

The following sub-studies were performed in subgroups of patients:

• Viral and immunologic dynamics and inflammation sub-study
• Bone sub-study
• Neurocognitive function sub-study