Deleted inclusion criterion allowing subjects with previous solid organ transplantation more than 1 year ago and rephrased to exclude solid organ transplantation < 1 year ago. Exclusion criterion was changed to allow enrolment of subjects with electrocardiogram (ECG) abnormalities associated with left ventricular hypertrophy. Further, cardiac insufficiency was added to the list of examples of clinically significant ECG abnormalities considered exclusionary. Exclusion criterion was revised and deleted the renal artery stenosis. Unilateral, bilateral and graft renal artery stenosis was added to the exclusion criterion. Specified that a decrease in estimated glomerular filtration rate (GFR) from baseline by more than 50% required discontinuation from the study. Specified that an Ora-plus and Ora-sweet preparation (not Ora-Blend) was used to prepare the extemporaneous suspension of valsartan. Acute dehydration and hyperkalemia were added to the requirements for discontinuation of study drug. The section describing the process for collecting information on screening failures was simplified. A description of the collection and reporting of suspected, unexpected serious adverse event (SUSARs) was added to the section on serious adverse event reporting.

Lowered the age limit from 1 year to 6 months old for entry criteria into the study ( EMA request) Included recommendation of External Safety Monitoring Committee ( ESMC) to enhance monitoring of liver function, renal function and serum potassium alert in all patients The screening period was started with Day -28. Inclusion criterion was elaborated in order to state that for all subjects, mean seated systolic blood pressure had to be equal to or greater than 95th percentile at randomization. Exclusion criterion was further revised to exclude subjects with previous solid organ transplantation less < 1 year prior to Visit 1.