( ether these inconsistencies were suffic...)Cobalis Reports Phase III Trial Results for PreHistin in Seasonal,Allergic Rhinitis,Health

ether these inconsistencies were sufficient to represent a systematic error that could affect the outcome of the analyses, the Company engaged an expert external consultant to conduct an audit of the electronic diary database. The study audit found that the electronic diary system functioned correctly and the diary data entered by the patients were correct. The inconsistencies noted earlier were primarily human errors that were corrected and did not alter the study outcomes.

About Seasonal Allergic Rhinitis

Seasonal allergic rhinitis, otherwise known as hay fever, is an allergic reaction to airborne substances such as pollen that get into the upper respiratory passages and cause the body to produce antibodies and release histamine. Histamine makes the upper respiratory membranes swell and produce typical allergy symptoms such as sneezing, runny nose and nasal congestion. In the U.S., approximately 50 million people suffer from seasonal allergic rhinitis, with related healthcare costs exceeding $7 billion annually. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with seasonal allergic rhinitis, or 30 million Americans. Current treatment options are mainly limited to symptomatic therapies to provide temporary relief and conventional allergy immunotherapy by injection.

About PreHistin

PreHistin is a sublingual lozenge that delivers its active ingredient through the buccal membrane directly into the bloodstream. The active ingredient, cyanocobalamin, has a well-known safety profile and has been shown in studies to relieve symptoms related to seasonal allergies, asthma and other atopic allergic diseases. PreHistin may represent a novel approach to treatment by rectifying imbalances in the immune system that trigger the over-production of allergy symptom-causing substances including histamines. By preventing or reducing the over-production of these substances before they are released from cells, the need to blo
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