Table 1

Flow chart of the study

Visit	Screening visit (V0)	Baseline (V1)	V2^† (1 month±7 days)	V3^† (3 months±7 days)	V4^† (6 months±7 days)	V5 (9 months±15 days)	V6 (date of V5+7 days)
Information	X
Written consent		X
Inclusion and non-inclusion criteria		X
Clinical assessment		X				X
Vital signs		X				X
Anthropometric measures		X				X
Blood samples		X				X
PCDAI/PUCAI*		X				X
Bone age		X				X
Bone mineral density		X				X
Concomitant treatments		X				X
Quality of life/fatigue score		X				X
AE and SAE*			X	X	X	X	X
Randomisation		X
Physical activity		X				X
Dietary assessment		X				X
Phone call			X	X	X		X

AE, adverse event; PCDAI, Pediatric Crohn’s Disease Activity Index; PUCAI, Pediatric Ulcerative Colitis Disease Activity Index; SAE, serious adverse event.