The general objectives of the REALISE study are to validate the benefits of the FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children.
The clinical trial will have two arms, randomized by school. One will be administered a single dose of the fixed-dose coformulation tablet, while the other, acting as an active control group, will receive
The clinical trial will have two arms, randomized by school. One will be administered a single dose of the fixed-dose coformulation tablet (), while the other, acting as an active control group, will receive a single dose of