Bone and Body Comp: A Sub Study of the SECOND-LINE Study

Exclusion Criteria

• •1. The following laboratory variables:
• •* absolute neutrophil count (ANC) \< 500 cells/µL
• •* hemoglobin \< 7.0 g/dL
• •* platelet count \< 50,000 cells/µL
• •* ALT \> 5 x ULN
• •2. Pregnant or nursing mothers
• •3. Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
• •4. Use of immunomodulators within 30 days prior to screening
• •5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
• •6. Intercurrent illness requiring hospitalisation
• •7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
• •8. Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
• •9. Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period