Carlsson, Mats http://orcid.org/0000-0002-1232-4681
Braddock, Martin
Li, Yuling
Wang, Jihong
Xu, Weichen
White, Nicholas
Megally, Ayman
Hunter, Gillian
Colice, Gene
Article History
First Online: 16 January 2019
Compliance with Ethical Standards
:
: This study was sponsored by AstraZeneca. AstraZeneca was involved in the study design, analysis, and interpretation of the data, and in the writing of this manuscript. Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described atExternalRef removed.
: Yuling Li was an employee of MedImmune, the biologics division of AstraZeneca, at the time the study took place; her current affiliation is CBT Pharmaceuticals. Jihong Wang and Weichen Xu are employees of MedImmune, the biologics division of AstraZeneca. Nicholas White is an employee of MedImmune and an AstraZeneca shareholder. Mats Carlsson, Martin Braddock, and Ayman Megally are employees of AstraZeneca, the sponsor of STRATOS 1 and STRATOS 2. Gene Colice is an employee of and holds stock options in AstraZeneca. Gillian Hunter is a consultant employed by AstraZeneca.
: STRATOS 1 and STRATOS 2 were performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements, and the AstraZeneca policy on Bioethics. All participating centers obtained approval from an independent ethics committee and all participants provided written informed consent.