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Article History

First Online: 22 May 2019

Compliance with Ethical Standards

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: This study was funded by Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim (Ingelheim am Rhein, Germany). Eli Lilly and Company funded the open-access fee. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

: All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

: The authors acknowledge Rajneeta Roy, an employee of Eli Lilly Scientific Services Private Limited for medical writing and editorial assistance.

: Viswanathan Mohan and Manoj Chadha have received speaker fees from Eli Lilly and Company, Novo Nordisk and Sanofi. Young Min Cho has received research support or consultant fees from Astrazeneca, Sanofi, LG chemicals, and Hanmi. Sanjay Kalra has received speaker fees from Eli Lilly and Company, Novo Nordisk, and Sanofi. Rakesh Kumar Sahay has received speaker fees from Eli Lilly and Company, Novo Nordisk, and USV India. Indranil Bhattacharya, So Yeon Kim, and Erik Spaepen are employees of Eli Lilly and Company. Chien-Ning Huang, and Kyu Jeung Ahn do not have any conflict of interest.

: The study was conducted in accordance with International Council for Harmonization Guidelines for Good Clinical Practice and the Declaration of Helsinki following approvals by the pertinent ethics boards. All patients provided written informed consent prior to entering the study.

: The data sets analyzed during the current study are not publicly available. Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available on request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever comes later. No expiration date of data requests is currently set once they are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment for up to 2 years per proposal. For details on submitting a request, see the instructions provided at .