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The first dose of trial medication was given under supervision by project staff at the first follow-up visit to the hospital or health centre where the child had been admitted, scheduled to be seven days after their discharge from hospital.
All regimens were given under supervision 30 min after a light meal following an overnight fast.
All doses of AL were given under supervision in all studies except A2401.
Compliance with the recommendation that IPTp drug should be given under supervision in the clinic was very low in this study.
Four standardized test meals of high- or low-fat and high- or low-protein content, all with the same carbohydrate amount, were given under supervision to each participant in random order over the four study days.
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Subsequent monthly doses of SP or placebo were given under the supervision of clinic staff until the end of the malaria transmission season.
Participating patients were managed as outpatients and doses were given under medical supervision, although at some centres patients could be hospitalised according to local practice, which ranged from 3 days at Mae Ramat Hospital, Thailand and at centres in Laos and India to 28 days at Mahidol University, Thailand.
The first dose of the study drugs was given under the supervision of the study nurse, who then provided the remaining doses to be taken at home.
All trial drugs were given under direct supervision with 200 ml tap water on an empty stomach after an overnight fast.
Dispersible amoxicillin tablets were prescribed as follows: 300 mg to children aged 2 11 months, 500 mg to those aged 12 35 months, and 650 mg to those 36 59 months of age, twice per day for 3 days 32– 34: the first dose was given under CHW supervision.
She said: "In the study the combined delivery of probiotic and oral immunotherapy was a safe and effective treatment for peanut allergy; however it is important to point out that this treatment must be only be given under close medical supervision as we are giving peanut to children who are allergic to peanut, and children did have allergic reactions".
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com