PROJECT SUMMARY The Data Management and Analysis Core (Core C) will interact importantly with each of the 4 projects, and the Scientific Core B. We have developed a detailed plan to optimize the synergy and interactions among the projects, cores and personnel involved in the studies proposed in this U19 application for a coordinated data analysis strategy. Notably, the members of each of the Projects and Cores are already interacting scientifically, and have published together in allergy research. Accordingly, should this renewal application be funded, the proposed work to advance our understanding of the pathology of human food allergy, and the mechanisms that contribute to therapeutic responses to oral immunotherapy with multiple food allergens (multi- OIT) with or without the biologic therapeutics omalizumab or dupilumab (the COMBINE trial) will represent a continuation and expansion of these ongoing collaborative efforts. The Data Management and Analysis Core has three Specific Aims: Aim 1: Provide data analysis and statistical support for the pilot phase 2 clinical trial of Project 1, evaluating whether treatment with multi-OIT combined with either omalizumab or dupilumab vs. multi-OIT alone results in a higher proportion of participants being able to pass a food challenge at week 24 (primary endpoint) and after a period of withdrawal at week 30 (a secondary endpoint) in multi-food allergic patients treated with multi-OIT, and also analyzing ongoing safety data collected in the course of the trial. Aim 2: Provide integrated and coordinated statistical analysis of the clinical and immunological assay data that will be collected by Projects 1, 2, 3 and 4, and the Scientific Core B, to attempt to identify immune system features that are predictive of whether or not multi-food allergic participants will achieve desensitization, or potentially sustained unresponsiveness after multi-OIT, and to attempt to identify immune system features that can be used to identify individuals at increased risk of experiencing adverse reactions to OIT. We will also analyze long-term follow up specimens from our prior ongoing POISED and completed MAPX trials, to assess whether there are correlations between immunological assay results and long-term clinical outcomes. Aim 3: Work with Project 1 and Scientific Core B to build and maintain databases organizing the clinical and laboratory data obtained in Projects 1, 2, 3 and 4 and Core B, to facilitate sharing and analysis of data from the COMBINE trial and projects, and also from long term follow-up studies of participants in our POISED and MAPX trials.