Table 1.

Visit schedule and assessments.

Parameter (if appropriate performed)	Visit 1 (baseline start)	Subsequent visits (intervals corresponding to routine clinical practice)
Informed consent	X
Patient code	X	X
Date of visit	X	X
Patient data (gender, date of birth)	X
Primary diagnosis (date, evidenced indication, indication-specific characteristics)	X
Family history	X
Pregnancy	X
Birth history	X
Previous auxological data	X
Physical examination	X
Relevant medical history and concomitant diseases	X
Concomitant medication/therapies	X	X
Previous clinical trial participation	X
Previous GH treatment	X
Omnitrope® treatment	X	X
Current auxological data	X	X
Vital signs	X	X
Pubertal development	X	X
Bone age	X	X
Body composition	X	X
Haematology	X	X
Blood chemistry	X	X
Glucose metabolism/OGTT	X	X
Fasting lipid profile	X	X
Urinalysis	X	X
Hormones (thyroid, gonadal, adrenal function)	X	X
IGF-I, IGFBP-3 determinations	X	X
Anti-HGH antibody determination	X	X
Adverse events		X
Pregnancy reporting		X
Medical device vigilance reports		X
Discontinuation (reasons)		X

IGF, insulin-like growth factor; IGFBP, insulin-like growth factor binding protein; OGTT, oral glucose tolerance test.