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The evaluations varied widely in regard to patient characteristics, regimens compared, and product dosing.
Subjects were considered in compliance if they missed no more than three product dosing days during the study.
Instead of reinforcing the product dosing strategy, the focus was on use of product in relation to planned or anticipated coital activity and participants developing their own plans for incorporating the product into their routine.
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For many medicinal products, dosing recommendations for children are based on extrapolation of results from adults.
After completion of the phase 1 study (28 days of follow-up for all study subjects), the scientific review committee will review the data and propose a cell product dose for the phase 2 study.
The increased transparency of the window also increases the yield value of the machine, due to a more efficient use of the generated electron beam, allowing increased processing speeds for a given product dose.
It is important to note for points 4 and 5, daily use of vaginally or rectally applied N9 by volunteers was well tolerated [37], [48], [49] and for point 6, the timing of when colposcopy or other testing is done in relationship to the last product dose was important [44], [50].
However, our meta-analysis showed no dose dependency, either in the number of cells or cell product administrations or in cell or cell product dose.
Since the product dose must match the dose in the human trial showing benefit, dose used in the study is an important consideration.
Our planned secondary analysis will be per protocol with all subjects who complete the 12 week intervention and are compliant based on consumption of ≥80% the product doses.
Perhaps, as other authors have suggested, we have yet to understand the optimal probiotic product, dose and duration to reach this infection prevention threshold.
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CEO of Professional Science Editing for Scientists @ prosciediting.com