-Ethics approval and consent to participate: The study was approved by the Ethics Committee of the Hospital Sant Joan de Déu with the reference and registered at ClinicalTrials.gov withEUDRAregistration number CT 2011-000337-36, ClinicalTrials.gov registration number: 2011-000337-36. Parents received an information sheet and signed written informed consent prior to the inclusion of infants in the study.
-Consent to publish: Notapplicable.
-Availability of data and materials: All data generated or analysedduringthisstudyareincluded in thispublished article [anditssupplementaryinformation files].
-Competing interests: Theauthorsdeclarethattheyhave no competinginterests.
-Funding: This study was financially supported by Official Grant from Spanish Health Ministry. The funding was in order to invoice the trial assurance, the Contract Research Organization and the analytical expenses and the statistical analysis. No other institutions have financed this research.Authors disclose any potential financial or ethical conflicts of interest regarding the contents of this submission.The authors have no conflicts of interest to this article to disclose.
-Authors' contributions:
-Dr IJ conceptualized and designed the study, designed the data collection instruments, collected data, coordinated and supervised data collection, analysis and interpretation of data, drafted the initial manuscript and reviewed and revised the manuscript.
-Dr AF, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr CA, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr EE, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr LA, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr CMA, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr MEE, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr FJL, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
-Dr MB, contribution to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
-Acknowledgements: Not applicable.