- May be unreliable including subjects who engage in excessive alcohol intake or drug abuse.- Subject has, in the opinion of the investigator, any clinically significant abnormalities in the clinical laboratory tests (serum chemistries, hematology or urinalysis) conducted at screening.- Subject has a history of hypercalcemia (consistent with elevated serum calciums above 10.5 mg/dl), illnesses that affect bone or calcium metabolism or recent nephrolithiasis or urolithiasis (within the previous 2 years).