The original protocol required an X-ray for determination of bone age (BA) at baseline (performed at the screening). However, at some sites, an X-ray had already been taken prior to the pre-screening visit. Therefore, to avoid repeated X-rays, the period for performing this X-ray was extended. An X-ray taken within 3 months prior to visit 2 was acceptable. "The difference between CA-BA ≥1" was an inclusion criterion in original protocol whereas "BA above 9 years in girls and above 10 years in boys" was an exclusion criterion. This was to reassure that the subject was at pre-pubertal stage upon enrolment of the trial and able to complete the 12-month treatment period prior to entering the puberty. However, the restriction of "CA-BA ≥1" was not relevant for younger children. Therefore, the inclusion criterion was changed to "BA/CA ≤0.9". The baseline GH level for inclusion was changed from "9 ng/mL" to "10 ng/mL" as this was the cut-point value for initiation of GH treatment. Any use of corticoid steroids and medications that could interfere with GH treatment was prohibited in the original protocol. However, some children may suffer from adrenocorticotropic hormone deficiency and for these children glucocorticosteroid treatments are mandatory as physiological replacement. Hence, glucocorticosteroid treatment was allowed as long as it was at a stable dose level. As per exclusion criteria in the original protocol, children with any diagnosed or suspected severe chronic disease or clinical signs of dysmorphic features, malformations, or mental retardation were not allowed to be included in the trial. However, a child with minor dysmorphic features or malformation in stable condition could be enrolled into the trial as long as it doesn't place the child at excessive risk by participating in the trial, and therefore, the exclusion criteria were changed.