Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Inclusion Criteria:

- Diagnosis of short stature (height maximum 2 standard deviations of mean for age and
gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)

- Naïve to growth hormone therapy

Exclusion Criteria:

- Known or suspected allergy to the trial product or related products

- Growth retardation attributable to causes other than GHD. Growth retardation
attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease,
chromosomal disorders or disease of the genitourinary, cardiopulmonary,
gastrointestinal or central nervous system; bone marrow transplantation or any
syndrome known to give short stature (examples are: Prader-Willi Syndrome,
Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)

- Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for
gestational age

- Pregnancy or the intention to become pregnant

- Breast-feeding

- Administration of other growth-altering medication