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S.K. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. She also takes the final responsibility for the decision to submit for publication. Conceptualization, S.K., D.P., N.T., U.R., and A.D.S.; Data curation, D.K.; Formal analysis, D.K. and R.G.; Funding acquisition, S.K. and D.P.; Investigation, S.K., G.P., S.B.M., and Y.K.; Methodology, S.K. and U.R.; Project administration, S.K., M.C., and K.P.; Resources, K.P., M.K.S., and D.P.; Software, D.K.; Supervision, K.P., M.K.S., N.T., and A.D.S.; Validation, R.G.; Writing—original draft, S.K.; Writing—review and editing, D.K., M.C., D.P., N.T., U.R., and A.D.S. All authors have read and agreed to the published version of the manuscript.
The Department of Obstetrics and Gynecology at KAHER’s JN Medical College (JNMC) Belagavi is deeply acknowledged. The Unit Chiefs (M.B. Bellad, Anita Dalal, Yeshita Pujar, and M.C. Metgud) deserve a special mention in providing valuable inputs and support during each phase of this study. We are indebted to the JNMC’s Blood Bank in the charge of Shrikant Viragi and his whole team for facilitating all on site biochemical work in the study. We are truly grateful to the resource and support teams at the Centre for Chronic Disease Control (CCDC) and Public Health Foundation of India (PHFI), Delhi. This trial is funded by Wellcome Trust-DBT India Alliance (December 2015–December 2020). The Young Scientist Award by DST SERB India (2013–16) helped us establish the DHANI trial. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication. Neither the product provider nor the sponsors had an opportunity to review a pre-submission copy of the article.
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
The trial was funded by India Alliance IA/CPHE/14/1/501498. The DST Young Scientist Award (SR/FT/LS-156/2011) also provided partial funding for setting up a part of the cohort. The supplements were donated by DSM Nutritional Products via their Mumbai office.
© 2021 by the authors.