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Patients gave blood serum samples prior to the treatment in 1992 fat and one year later pills in 1993. They were immunoassayed for specific fat IgE antibodies pills using a chemi-luminescent technique. Statistician fat Bradley Rosebrook ran T-Tests comparing average pills baseline IgE levels to one-year. For the seasonal fat allergens reported, the active group (n=34) had on average a greater reduction in pills IgE than the placebo group (n=33).7 On August 14, 1996 representatives of Broncorp, Inc. met with the Division Director, Dr. John Jenkins, and 14 other FDA officials of the Pulmonary Division at a PreNDA fat meeting. Dr. Mansfield made a presentation on the 1995 study data (n=165) from Oregon, Washington and Idaho. He noted that together the data failed to show statistical superiority of vitamin B12 on the primary endpoint. He noted that in Washington and Idaho, during the later part of the study, there was a drop in the pollen counts and marked improvements in symptoms in both the vitamin B12 and placebo groups. (This made a therapeutic benefit of the B12 treatment difficult to demonstrate.) But pills that the pollen counts in Oregon fat remained higher throughout the study and that the data from Oregon showed a significant difference between the active and placebo groups.8

In January 1997, 62 subjects who had been the placebos in the 1995 study were invited to receive the vitamin B12. In June 1997, the 62 placebo subjects were sent a questionnaire asking: How would you compare your overall allergy (hay fever) symptoms this spring to the last two springs? 20 people responded, with 15 reporting having had the B12 treatment, and 5 not. 12 of the 15 reported at least a slight improvement in overall allergy symptoms, and 1 of the 5. Improvement ratios - 12:3 having received treatment, 1:4 not having received treatment.8 A bioequivalence study showed that a 3000 mcg lozenge delivered an equivalent amount of cyanocobalamin to the blood as a 15 mcg injection.9 From the spring to the summer patients with demonstrated allergic rhinitis received with the cyanocobalamin (or placebo) containing lozenge twice daily for 21 consecutive days. All subjects also received C and B oral multivitamins for 21 days. Twice daily subjects maintained a nine-week diary on sneezing, runny nose, nasal congestion, pills itchy eyes, itchy nose and antihistamine (chlorpheniramine) use. In the post-treatment period, the active group (n=15) recorded on average a greater reduction in symptoms and in antihistamine use than the placebo group (n=9). The results yielded reductions (0.1>p>0.01) fat in total weekly pills symptom/rescue fat medication for the active group compared to the placebo for pills weeks 2, 6, 8 and 9. The results tend to replicate those of the studies on injectable cyanocobalamin.10

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