A Study to Assess Growth in Children With Idiopathic Short Stature

Exclusion Criteria

• •1. Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.
• •2. Known presence of one or more pituitary hormone deficiencies
• •3. Bone age advanced over chronological age by more than 3 years.
• •4. For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).
• •5. For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs.
• •6. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .