Funding for this research was provided by:
Text and Data Mining valid from 2018-04-05
Received: 25 May 2017
Accepted: 15 March 2018
First Online: 5 April 2018
Ethics approval and consent to participate
: All participants (or their legal representative) provided written informed consent prior to screening, and the final study protocol, amendments, and informed consent documentation were reviewed and approved by the Institutional Review Boards or Ethics Committees at each participating center (listed in Additional file InternalRef removed), including those that had not yet recruited participants when the study was terminated (Australia and France). The study was conducted in compliance with the declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines.
: All authors approved the final version of the manuscript for submission.
: TF, BB, MD, PL, and JMa are employees of the study sponsor, Pfizer. JK and JB were employees of Pfizer at the time the study was conducted. JMi was a contracted employee of Pfizer at the time the study was conducted. WD participated in the design and execution of this study as a contracted Pfizer employee.
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