Impact of a Novel Digital Therapeutics System on Nonalcoholic Steatohepatitis: The NASH App Clinical Trial.

"CONFLICTS OF INTEREST Guarantor of the article: Masaya Sato, MD, PhD. Specific author contributions: The 15 authors are justifiably credited with authorship, according to the authorship criteria. M.S. conception, design, drafting of the manuscript, acquisition of the data, and final approval given; M.A., T.S., T.I., M.Y., S.M., J.I., and T.N.: acquisition of the data, final approval given; R.T.: critical revision of manuscript, supervision, final approval given; N.Y.: acquisition of the data, final approval given; T.U., T.O., and M.F.: supervision, final approval given; E.H.: data analysis, critical revision of manuscript, and final approval given; K.K.: critical revision of manuscript, supervision, and final approval given. Financial support: This study was supported by CureApp Inc. (Tokyo, Japan). Potential competing interests: E.H. has a consultation contract as a biostatistician with CureApp Inc. No other authors have conflict of interest to declare. Data availability: The data that support the findings of this study will be made available by the corresponding author upon reasonable request."

"Financial support: This study was supported by CureApp Inc. (Tokyo, Japan)."

"This study was a multicenter, single-arm, 48-week trial performed to evaluate the efficacy of a smartphone app (NASH App) –based intervention for patients with NASH. All patients were asked to download the NASH App on their phone, while the attending physicians were provided with the NASH App Console, a web-based patient management console, for 48 weeks. This project was approved by the Ethics Committee of the University of Tokyo (2018035SP), and all patients provided written informed consent. The trial was performed in accordance with the ethics principles of the Declaration of Helsinki and was registered in the University Hospital Information Network Clinical Trial Registry (UMIN000029835) and the Japan Registry of Clinical Trials (jRCT) (No. jRCTs032180372). All authors had accessed to the study data and had reviewed and approved the final manuscript. The sponsor (CureApp) assisted with the trial design and performed site monitoring and data management under a third-party audit."