CY2021 Standard MAPD 5T_21333_353_441
The dossier included the clinical study report for Period III of the trial which was an open label, 44 week (week 8 to 52) extension study. There were 1684 subjects who entered the extension and were treated with olmesartan 40 mg + amlodipine 5 mg. This was uptitrated to amlodipine 10 mg if their BP was not adequately controlled. ................
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