Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first-line therapy (TAILOR study): a study protocol for a phase III, open-label, multicentre, randomised controlled trial.

"Declarations Ethics approval and consent to participate {24}The study is conducted according to the principles of the Declaration of Helsinki and in accordance with Dutch Law on research with humans (Medical Research Involving Human Subject Act (WMO)). Central ethical approval has been confirmed from the medical research ethics committee of the Leiden University Medical Center on 13 December 2021. Important protocol modification will be communicated to the central and local ethics committees. Written, informed consent to participate will be obtained from all participants. Consent for publication {32}Not required; the study results that will be published in the future will not contain any data from any individual person. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28}The authors declare that they have no competing interests. Although the LUMC pharmacy procures Envarsus at a discounted rate, this arrangement has no bearing on the study and is unrelated to the content of this manuscript. Competing interests {28} The authors declare that they have no competing interests. Although the LUMC pharmacy procures Envarsus at a discounted rate, this arrangement has no bearing on the study and is unrelated to the content of this manuscript."

"Funding {4} AECS, MET and BvH received a ZonMW grant (nr 10140022010001) and funding from Chiesi Pharmaceuticals b.v. (project number: PA 2019–71111) for this study."

"Trial registration ClinicalTrials.gov NCT05221411. Retrospectively registered on 3 February 2022; EudraCT number 2021–003420-33. Prospectively registered on 16 June 2021."