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Amitriptyline at low-dose and titrated for irritable bowel syndrome as second-line treatment (The ATLANTIS trial): protocol for a randomised double-blind placebo-controlled trial in primary care

Crossref DOI link: https://doi.org/10.1186/s13063-022-06492-6

Published Online: 2022-07-08

Published Print: 2022-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Alderson, Sarah L.

Wright-Hughes, Alexandra

Ford, Alexander C.

Farrin, Amanda

Hartley, Suzanne

Fernandez, Catherine

Taylor, Christopher

Ow, Pei Loo

Teasdale, Emma

Howdon, Daniel

Guthrie, Elspeth

Foy, Robbie

Ridd, Matthew J.

Bishop, Felicity L.

Muir, Delia

Chaddock, Matthew

Herbert, Amy

Cooper, Deborah

Gibbins, Ruth

Newman, Sonia

Cook, Heather

Longo, Roberta

Everitt, Hazel
Funding

Funding for this research was provided by:

Health Technology Assessment Programme (16/162/01)
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Text and Data Mining valid from 2022-07-08

Version of Record valid from 2022-07-08
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Article History

Received: 28 December 2021

Accepted: 24 June 2022

First Online: 8 July 2022

Declarations

:

: Informed consent will be obtained from participants prior to entry into the trial. The trial was reviewed and received ethical approval from Yorkshire & The Humber Research Ethics Committee on 5 August 2019 (19/YH/0150; Additional file InternalRef removed), the Medicines & Healthcare products Regulatory Agency (EudraCT: 2019–000324-17), the Health Research Authority (IRAS project ID 252282), and local CCGs/R&D departments for each participating site prior to entering patients into the trial. The study is sponsored by the University of Leeds.

: No data on individual persons are used in the manuscript.

: The authors declare that they have no competing interests.

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