Table 1.

Exclusion Criteria.

• Known or suspected hypersensitivity to trial product(s) or related products

• For female patients, pregnancy, breast-feeding, or the potential to become pregnant (specific criteria varied in some countries). Males of reproductive age were excluded if they or their partner(s) were not using adequate contraceptive methods

• Active malignant disease or history of malignancy, with some exceptions

• History of pituitary adenomas or other benign intracranial tumors, unless the tumor had been surgically removed >12 months before randomization or the patients had stable and clinically non-functioning adenomas for ≥3 years, with the most recent scan within 9 months prior to randomization

• Clinically significant renal or hepatic disease

• A history of positive tests for hepatitis B and/or C or for human immunodeficiency virus antibodies

• Acute severe illness associated with weight loss <180 days prior to randomization

• Active Cushing’s syndrome <24 months prior to randomization

• Heart insufficiency (NYHA class >2)

• A history of acromegaly

• Use of systemic corticosteroids other than in replacement doses within 90 days before randomization

• Mental incapacity/language barriers which precluded adequate participation