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A common practice is to cover the active capsule with a larger capsule; participants are unaware if their capsule contains the active capsule or an inert substance.
There was a significant dose response effect at the second meal, indicating that each extra active capsule reduced the incremental AUC by ∼6 units or ∼3 4%.
In many cases the placebo capsule had a different coloured cap to that of the active capsule but this was not remarked on in the report.
However, when the company realized that the active capsule contained a penicillin-like drug they were unable to participate, as they do not have a license for penicillin.
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(Patrick says Terrence put in nothing).Soon-Shiong was also fixated on the concept of wrapping other drugs inside biologically active capsules to unlock more of their power and curb their side effects.
The placebo and active capsules were obtained from the manufacturer of the drug (Folinoral®, Laboratoires Therabel Lucien Pharma, Levallois-Perret, France).
Both placebo and active capsules contain an antioxidant, i.e. 0.2% alpha-tocopherol (vitamin E).
Men who consented were randomised to both a lycopene (active capsules, placebo capsules or 1 2 portions of cooked tomatoes per day) and a green tea dietary component (active capsules, placebo capsules or 3 cups of green tea per day) for six months.
In the active capsules, the excipients lactitol and glucose were chosen both as diluents and as nutritive growth medium for the lactobacilli.
27 29 In the first of these, the methods of blinding by Berven et al 27 were clearly reported: "capsules had the same size and appearance and were indistinguishable from the active capsules".
Placebo capsules were matched in number, shape, size, colour and odour to the active capsules and were packaged in identical opaque containers by independent staff not involved in the trial.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com