2.4.2. Randomization and masking.
cedar pollinosis
After obtaining written informed consent, we collected the age and sex of the participants. When the number of eligible participants reached 40 in both the healthy subjects and the patients with Japanese cedar pollinosis, these participants were enrolled.In this study, a static allocation table adjusting sex and age (20–40/41–60) was made by the Clinical Study Support Center at Wakayama Medical University Hospital. Participant lists including test ID, subject status (healthy subjects/patients with Japanese cedar pollinosis), age and sex were sent to assignment staff in January 2018, who performed the allocation according to the table. The allocation results were then sent to a facilitator, who labeled the boxes containing test foods according to the results of allocation with ID for testing purposes. The individuals related to the allocation were not connected with the research staff, and all research staff and enrolled participants were unaware of the actual allocations. All data were fixed on October 9,2018, and the allocation key opening was performed. Data were analyzed by a statistician at the Clinical Study Support Center at Wakayama Medical University, according to the statistical analysis plan.