Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus
Brief Summary: To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus


Options:
A: Inclusion Criteria:

* Outpatients \> 18 years
* Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
* Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
* BP thresholds at visit 1:

  * For patients previously treated and uncontrolled: 140≤ office SBP\<180 mmHg
  * For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
* BP thresholds at visit 2 (for all patients):

  * 160≤office SBP\<180 mmHg AND
  * 155≤home SBP\<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

Exclusion Criteria:

* Women of child-bearing potential not using any effective methods of contraception
* Severe hypertension (office BP ≥ 180/110 mmHg)
* Impossibility to stop abruptly previous antihypertensive treatments at visit 1
* Patients previously untreated or patients treated with two or three antihypertensive medications
* History or evidence of a secondary form of hypertension
* History of hypersensitivity to ACEi or renin inhibitors
* History of heart failure, stroke or coronary heart disease
* Serum potassium ≥ 5.2 mmol/l

Other protocol-defined inclusion/exclusion criteria may apply
B: Inclusion Criteria

* Patients with essential severe hypertension Exclusion Criteria
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.
* Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply
C: Inclusion Criteria

* Patients with essential hypertension
* Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply
D: Inclusion Criteria:

* msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
* Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
* Must be able to swallow minitablets (2mm in diameter) administered in soft food
* Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Exclusion Criteria:

* Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
* Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
* msSBP ≥ 25% above the 95th percentile
* Second or third degree heart block without a pacemaker
* AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range
* Total bilirubin \> 2 times the upper limit of the reference range
* Creatinine clearance \< 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate \[GFR\]), based on the serum creatinine concentration obtained at the screening visit)
* WBC count \< 3000/mm³
* Platelet count \< 100,000/mm³
* Serum potassium \> 5.2 mEq/L
* Other protocol-defined inclusion/exclusion criteria may apply

Answer: C