2.11. Randomized, Double-Blind, Placebo-Controlled Trial Design
ALLERGY
The randomized, double-blind, placebo-controlled trial on PAR was designed in accordance with the guidance for developing drug products for AR treatment published by the Division of Pulmonary, Allergy, and Rheumatology Products in the Center for Drug Evaluation and Research at the Food and Drug Administration (April 2000 version). All patients who met the eligibility criteria were randomized to either the probiotic-treated or control group. In total, 137 patients were double-blinded and randomized to four groups, namely, one placebo group and three groups that received live GM-080 at different dosages: group A (2 × 10