Original ResearchFull Report: Clinical—Alimentary TractCrohn’s Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial
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Conflicts of interest These authors disclose the following: AL reports grants, from Nestlé Health Science, and grants from Janssen unrelated to this field; advisory boards, travel, speaker fees or DSMBs from Celgene, Takeda and AbbVie, and a licensing and consulting agreement with IP with Nestlé health to develop new products based on diet. EW reports personal fees from Janssen, personal fees from AbbVie, outside the submitted work. RSB reports personal fees from Consulting to Nestlé Health Science, during the conduct of the study; personal fees from Invited speaker by Nestlé Health Science, personal fees from Invited speaker by Takeda, outside the submitted work. RS reports personal fees from Janssen, AbbVie, Mead Johnson, Lapidot and Abbott, outside the submitted work. JVL reports consulting, travel and/or speaker fees and research support from AbbVie, Janssen, Nestlé Health Science, Merck, P&G, GSK, Illumina, Otsuka. The remaining authors disclose no conflicts.
Funding Initial funding for the study in Israel was provided by unrestricted grants from the Azrieli Foundation and Nestlé Health Science to AL. Nestlé Health Science also kindly provided Modulen to all participating sites to ensure uniformity of the formula used among participants and provide the formula to enrolled patients for the duration of the study. The conduct of the study in Canada (Halifax, Edmonton) was supported by local divisional funds, a Women and Children's Health Research Institute (WCHRI) Research Capacity Building Award (EW) and a Canadian Institutes of Health Research (CIHR) New Investigator award (JVL). The funders of the study had no role in the design of the study, data collection or analysis, interpretation of data, writing of the report, or in the decision to submit the paper for publication. None of the funders or participating physicians had access to the data. All data were held confidentially by a single research coordinator and data manager who validated the data and performed an extensive query process (RSB).
Author names in bold designate shared co-first authorship.
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Authors share co-senior authorship.