Fig. 1

Participant timeline. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure [20] (Additional file 1) for the study schedule of enrolment, interventions and assessments. Baseline assessments will occur at -t_1–0 prior to allocation. Follow-up will occur at time points between t₁ and t₅ (1, 3, 6, 9 and 12 months after allocation). Adverse event monitoring will occur after allocation at t₂, t_3, t₄ and t₅ (3, 6, 9 and 12 months); HbA1c, LDL, HDL, total cholesterol, triglycerides, fasting blood glucose and insulin will be collected at –t_1–0, t₀ (baseline), t₁ (1 month) t₃ (6 months) and t₅ (12 months). Close-out assessments will occur at t₅ (12 months)