Table 1.

Flow chart of this trial

Visits	Screening	Follow-up
		Visit 1	Visit 2	Visit 3	Visit 4–13	Visit 14	Visit 15
Time points	−2 weeks	Week 0	Week 2	Week 4	4-week interval	Week 48	Week 52
Informed consent	√
Medical history	√
Physical examination	√		√	√	√	√	√
HbsAg	√
T-SPOT	√
BILAG	√			√	√	√	√
SLEDAI	√			√	√	√	√
PGA	√			√	√	√	√
SFI			√	√	√	√	√
Lab routine*	√			√	√	√	√
ANA profile	√
Anti-dsDNA	√			√	√	√	√
C3 and C4	√			√	√	√	√
Randomisation		√
Belimumab/placebo	√	√	√	√	√	√
Concomitant medication	√		√	√	√	√	√
Adverse event	√	√	√	√	√	√	√

*Includes complete blood cell count, urine routine test, hepatic and renal function, C reactive protein and erythrocyte sedimentation rate.

BILAG, British Isles Lupus Assessment Group; PGA, Physician’s Global Assessment of disease activity; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index; SFI, SELENA-SLEDAI Flare Index.