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Furthermore, they provided the study product and assisted with production of the placebo.
There was one serious adverse event, not related to study product and one severe event (oral paresthesia) in the 0.2% CHX-alcohol group which did resolve.
As a preliminary study, product images and advertisements were collected from the websites in November 2013.
None of these events was considered related to study product.
Adherence data included participants who discontinued study product for any reason, including those instructed to discontinue study product by study staff.
All adverse events were graded for severity and relationship to study product.
Participants were instructed to use the study product only in their vagina.
The first application of study product was supervised in the clinic.
No participant was discontinued from study product by the study staff due to an AE.
Pregnant women were allowed to resume study product use after pregnancies had ended.
No participant was discontinued from study product by study staff due to an AE.
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