Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial.

"Declarations Ethics approval and consent to participateNo serious or lasting side effect of this type of treatment and no compensation claims have been reported for this type of treatment in this age group in Denmark. As no standardised and effective treatment exists in this area, there was no compelling treatment that the child missed out on by participating in the trial. The study was approved by the Regional Committee on Health Research Ethics (S-2015001), and data were handled according to regulations by the Danish Data Protection Agency. The Regional Committee on Health Research Ethics reviewed an annual safety report and any amendments made in the protocol or the documents used in the trial. All parents gave written informed consent for their child to participate in the study. The parents could withdraw their child from the study at any time without consequences for their child. Consent for publicationNot applicable. Competing interestsAll authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf.They declare that LVH has received grants from the Foundation for Chiropractic Research and Postgraduate Education, the European Centre for Chiropractic Research Excellence, the Fund for General Practice, the General Practitioners’ Foundation for Education and Development, and the Research Fund for the Region of Southern Denmark at different times during the project period; LH and HWC have received grants and are supported partly by the Foundation for Chiropractic Research and Postgraduate Education; JS and DJ have no financial relationship with any organisation that might have an interest in the submitted work in the previous 3 years; no other relationship or activities that could appear to have influenced the submitted work. Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. They declare that LVH has received grants from the Foundation for Chiropractic Research and Postgraduate Education, the European Centre for Chiropractic Research Excellence, the Fund for General Practice, the General Practitioners’ Foundation for Education and Development, and the Research Fund for the Region of Southern Denmark at different times during the project period; LH and HWC have received grants and are supported partly by the Foundation for Chiropractic Research and Postgraduate Education; JS and DJ have no financial relationship with any organisation that might have an interest in the submitted work in the previous 3 years; no other relationship or activities that could appear to have influenced the submitted work."

"Funding The study was primarily funded by the Foundation for Chiropractic Research and Postgraduate Education. The European Centre for Chiropractic Research Excellence, the Fund for General Practice, General Practitioners’ Foundation for Education and Development, and the Research Fund for the Region of Southern Denmark also made a financial contribution. The funding sources had no role in the design of the study; in the collection, analyses and interpretation of the data; in the writing of the report or in the decision to submit the article for publication."

"Trial registration Clinical Trials NCT02595515, registered 2 November 2015."