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Both study products were generally well tolerated.
Safety and tolerability of the study products were in line with known side effects of diazoxide.
Another important remark is that we do not consider in our study products based on the incorporation of HS into compound NPK granules with the aim of also having biostimulant (DE) effects.
Enrolled participants received 14 identical, pre-filled, single-use applicators containing 3.5 g of one of the study products: VivaGel® or placebo gel.
Similarly, of 78 AEs occurring in placebo recipients within 28 days after administration, 15 (19.2%) were judged related to study products before unblinding.
A larger similar trial among primary dysmenorrheic young women with longer treatment phase and multiple batched study products can determine the definitive efficacy of this historically documented formula.
The second case of hepatitis B occurred with a rise in ALT to 1,371 U/L on study day 90, a month after all 3 rabies vaccine immunizations had been completed, and was deemed not related to study products.
The study physicians did not share their own examination results, did not know the identity of the participants, did not handle the study products, and did not know the assigned treatment.
Both study products were stored at 2° to 8°C.
Study products were produced at Chr. Hansen A/S.
The study products were administered with a drinking straw.
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