- Volunteers with severe renal impairment must also meet the following inclusion criteria: 1. Consistent with the disease process causing the chronic renal failure and associated symptoms, otherwise judged to be in good health in the opinion of the investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening). 2. Volunteers with severe renal impairment with an estimated glomerular filtration rate (eGFR) = 29 mL/min/1.73m2, who are not on dialysis and are not expected to start dialysis in the next 3 months. 3. Severity of renal disease has to be stable: no significant change in renal function as evidenced by the serum creatinine value within ±25% from the last determination, obtained within at least 6 months before study entry. 4. Volunteers with diabetes mellitus can be included provided that the disease is controlled (i.e., HbA1c <7%). 5. Stable treatment regimen for renal impairment from 2 months prior to treatment start. Diuretics are allowed when needed. 6. Concomitant medications to treat underlying disease states or medical conditions related to renal insufficiency may be used, except when specifically excluded by name or pharmacological class, and provided that dosages are stable for at least 2 months prior to treatment start.