 An update was made to the emergency safety procedures. In particular, it was clarified that any SAE had to be reported within 24 hours using the SAE form available in the eCRF. Faxing an SAE form could be done in case of technical issues (backup procedure).  The nonclinical results, clinical results, and study rationale sections in the introduction were updated with information from recently completed studies.  A minimum baseline GH value was added to the inclusion criteria (GH at baseline > 2.5 μg/L).  The following exclusion criteria were added: - Subjects with additional active malignant disease within the last 5 years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix); - Subjects with a marked baseline prolongation of QT/QTc interval, i.e., a mean QT/QTc > 450 ms after 3 consecutive measurements at least 5 minutes apart; - Subjects with abnormal coagulation, prothrombin time, or activated partial thromboplastin time increased by 30% above normal limits; - Subjects who had a history or presence of pancreatitis at the moment of the screening visit; - Subjects with severely decreased renal function (serum creatinine > 2.0 mg/dL or 176 μmol/L).  It was clarified in the section on study procedures that at screening, if it was necessary to confirm the active acromegaly by 2-hour 5 –point mean GH and oral glucose test that the instructions provided in the laboratory manual needed to be followed.  was clarified that a subject diary would be used in the study and specified throughout the section on study procedures when this diary needed to be collected.  The summary of risk management was updated with the most recent information.  The PK Analysis Set was added to the statistical methods section.  It was corrected in the statistical section that the interim analysis was not blinded.

 Serbia was added to the list of participating countries.  The criterion excluding subjects with significant cardiovascular morbidity within the 3 months preceding enrolment was updated to “subjects who had had a significant cardiovascular disease in the 3 months prior to inclusion such as congestive heart failure (New York Heart Association class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, sustained clinically significant bradycardia, advanced heart block, or with a history of acute myocardial infarction.”  A recommendation on dose adjustment of beta-blockers, calcium channel blockers, or medicinal products to control the electrolyte balance and insulin and antidiabetic agents was added to the section on concomitant medication. In addition, a recommendation on clinical monitoring for HR in case bradycardic agents were used was added.  HcAb1 was added to the list of clinical chemistry parameters to be evaluated.