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

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