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The analyses were conducted using the maximum licensed dose of sitagliptin (100 mg) and the licensed dose of linagliptin (5 mg).
As β-cell dysfunction is progressive, treatment is required, and low-dose sulphonylureas (12.5% or less of the maximum licensed dose) appear to be effective for HNF4A diabetes, 51 which is similar to the response seen with HNF1A diabetes.
Patients randomized to the reference treatment OROS-MPH in study 325 were individually optimized to 18, 36, or 54 mg/day (OROS-MPH was administered according to European regulations with a maximum licensed dose of 54 mg/day) [ 25].
Comparator NSAIDs were given at the maximum licensed dose; these were naproxen 1,000 mg, ibuprofen 2,400 mg, diclofenac 100 to 150 mg, and loxoprofen 180 mg daily.
Patients received either remifentanil (0.1 to 1 μg/kg per minute [exceeding the maximum licensed dose of 0.74 μg/kg per minute]) and propofol (0.5 to 4.0 mg/kg per hour, added only in the case of insufficient sedation at maximal remifentanil dose), or fentanyl (1.0 to 7.0 μg/kg per hour) and midazolam (0.02 to 0.2 mg/kg per hour).
OROS-MPH was administered according to European regulations (maximum licensed dose, 54 mg/day) [ 15].
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9. Clinical trials of coxibs designed to demonstrate gastrointestinal safety, have used doses of coxibs higher than the maximum licensed daily dose [ 13- 15] for arthritis.
In trials lasting 26 weeks or longer, 40,596 patients received NSAID at maximum licensed daily doses or a coxib within the licensed dose range.
In 41,608 patients involved in trials lasting 4 to 12 weeks, 6,581 received placebo, 502 paracetamol 4,000 mg daily, 12,093 traditional nonselective NSAIDs at maximum licensed daily doses, and 21,892 received a coxib within the licensed dose range.
If treatment fails, doctors increase the dosage up to four times the licensed dose.
The AmBiLoad study was designed to clarify whether higher doses of L-AmB could be more efficacious than the licensed dose of 3 5 mg/kg.
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CEO of Professional Science Editing for Scientists @ prosciediting.com