All cases coded as 'Work Activity'Probableble Work Activity' and 'Other Activity' were classified using the same classification approach described in the method section.
Activities were classified using signed Phase I budgets, not effective disbursements or expenditure.
Ambulatory status was classified using the Barthel Index of Activities of Daily Living and the Harris Hip Score.
Physical inactivity was classified using the WHO recommendation on physical activity for health.
(2) CWP was classified using American College of Rheumatology criteria.
Activity levels will be classified using Evenson's cut-off values [ 41].
Activity intensity categories were classified using the following previously published cut points (sedentary: 0 299; light: 300 3580; moderate: 3581 6129; vigorous: ≥6130).
For physical activity, counts per minute will be classified using predetermined tri-axial vector magnitude cut-points for light, moderate, hard or very hard 0 2690, 2691 6166, 6167 9642, and >9642 counts per min respectively [ 94].
AEs were classified using Medical Dictionary for Regulatory Activities (MedDRA) terminology, and clinical laboratory results were assessed using the grading criteria of the National Institute of Health Common Toxicity Criteria for Adverse Events (NIH CTCAE).
Adverse events (AEs) and serious adverse events (SAEs) were classified using the Medical Dictionary for Regulatory Activities (Version 12.1).
