Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.
Born SGA (birth length and/or weight standards).
Height below -2.5 SD at screening (19-29 months of age). At least one measurement of
length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners
Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational
age), if associated with dysmorphic features.
Severe prematurity (Gestational Age (GA)
(defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement
Severe familial short stature defined as: Father's height below 155 cm or mother's height
below 145 cm.
Defined neurological defects and/or severe neurodevelopmental delay.