Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)

Exclusion Criteria

• •Prior treatment with any growth promoting agent
• •History of, or current, significant disease
• •Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome
• •Birth weight and/or birth length less than 5th percentile for gestational age
• •A diagnosis of Attention Deficit Hyperactivity Disorder
• •Daily use of anti-inflammatory doses of glucocorticoid
• •Prior history of leukemia, lymphoma, sarcoma or cancer
• •Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening
• •Significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants
• •Significant abnormality in screening laboratory studies