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15 A significant nuance of this system is the NCE-1 provision, which allows a generic manufacturer to file an ANDA with a Paragraph IV certification four years after the NCEs approval, provided they challenge at least one of the patents listed in the FDAs Orange Book

METHODS We conducted a phase 2, double-blind, randomized, placebo-controlled trial involving adults who had a body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of 30 or higher or who had a BMI of 27 to less than 30 plus at least one weight-related condition

Durrani T, Clapp R, Harrison R, Shusterman D

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