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Subjects deemed at risk with further dosing will not be treated further with primaquine.
Since approval for children is lacking for long-term use, the issue of dosing will not be addressed further.
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The doses will not be used even in safety or clinical trials.
The approved doses will not be strong enough to kill the viruses responsible for many outbreaks of food poisoning.
In case of simultaneous outbreaks in megacities the current emergency stockpile of yellow fever vaccine of 6 million doses will not be sufficient to protect the large populations from the disease [4].
But still, enthusiasm has to be dampened, because these doses will not be attained pharmacologically.
Adjustment of the vildagliptin dose will not be allowed throughout the study.
If 2/3 patients suffer from DLT the dose will not be escalated.
For patients who are on UDCA, the dose will not be changed during the period of study.
If one or more further DLT events are seen the dose will not be escalated and no does will be recommended for phase II.
Tapering of NRT dose will not be explicitly advised, but dosage and frequency of use will be closely reviewed during fortnightly telephone support.
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