Versartis Long-Term Safety Study of Somavaratan

Exclusion Criteria

• •1. Withdrawal from a somavaratan clinical study.
• •2. Use of certain medications with potential to alter responses to the test product.
• •3. Presence of a significant medical condition.
• •1. Prior/concomitant treatment with any growth promoting agent.
• •2. Current, significant disease.
• •3. Chromosomal aneuploidy, significant gene mutations or confirmed diagnosis of a named syndrome.
• •4. Birth weight and/or birth length less than 5th percentile for gestational age.
• •5. Prolonged daily use of anti-inflammatory doses of oral glucocorticoids.
• •6. Prior history of malignancy.
• •7. Treatment with an investigational drug in the 30 days prior to screening.
• •8. Known allergy to constituents of the study drug formulation.
• •9. Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening.
• •10. Significant spinal abnormalities including scoliosis, kyphosis, Chiari malformation, and spina bifida variants.
• •11. Significant abnormality in screening studies.
• •12. History of pancreatitis or undiagnosed chronic abdominal pain.
• •13. History of spinal or total body irradiation.
• •14. Other pituitary hormone deficiencies that are not properly treated.