Fig. 2
Schedule of study enrolment, interventions and assessments. 1Intervention and assessments to continue after week 16 only where fractures are unhealed at week 16; 2Serum 25-hydroxyvitamin D < 30 nmol/L, deficient; ≥30 nmol/L, not deficient; 3Daily subcutaneous injection (20 μg/day); 4Magnetic resonance imaging (MRI) scans to cease when fracture is radiologically healed; 5Clinical assessments twice weekly after fracture is radiologically healed, and to cease when fracture is clinically healed; 6Weekly visual analogue scale; 7Short Form (36) Health Survey; 8Adverse events recorded for 4 weeks after participant’s final study visit (i.e. until weeks 20 or 28). 9Safety and research blood biochemistry; 10Safety and research urine biochemistry; 11Dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine and hips (allocation and week 16 only); peripheral quantitative computed tomography (pQCT) scan of the diaphyseal tibia; and high-resolution pQCT (HR-pQCT) scan of the metaphyseal tibia and radius; 12Accelerometer worn 24 h/day and replaced four-weekly; 13Review of Army medical records for 5 years after participant’s final study visit; 14Columbia-Suicide Severity Scale for all at allocation, and four-weekly for participants allocated to the intervention arm; 15Review of Army fitness records; 16Pregnancy test for all at allocation, week 16 and 24, and four-weekly for participants allocated to the intervention arm