 6. Has advanced bone age BA 1 year and BA is less than or equal to 11.5 years in females or 12.5 years in males OR predicted adult height 150 centimeter cm in females or 160 cm in males OR standard deviation score SDS -2 standard deviations SD OR rapid growth defined as growth of BA growth of chronologic age 1. BA is determined by Greulich and Pyle standards or Tanner-Whitehouse 3 TW3 standards at screening. 