Wedzicha, Jadwiga A.
Singh, Dave
Tsiligianni, Ioanna
Jenkins, Christine
Fucile, Sebastian
Fogel, Robert
Shen, Steven
Goyal, Pankaj
Mezzi, Karen
Kostikas, Konstantinos
Funding for this research was provided by:
Novartis (-)
Article History
Received: 25 October 2018
Accepted: 1 January 2019
First Online: 8 January 2019
Ethics approval and consent to participate
: The FLAME study protocol and all amendments were reviewed by an Independent Ethics Committee or Institutional Review Board for each center in each country (Japan, Korea, Latvia, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, Thailand, Croatia, Serbia, Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Italy). The study was conducted as per the guidelines in the Declaration of Helsinki and Good Clinical Practice guidelines.
: Not applicable.
: Jadwiga A. Wedzicha (JAW) has not received any speaker or consulting fees since January 2015. She has received research grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Johnson and Johnson. Dave Singh (DS) reports grants and personal fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Glenmark, Johnson and Johnson, Merck, NAPP, Novartis, Pfizer, Takeda, Teva, Theravance, and Verona, and personal fees from Genentech and Skyepharma. Ioanna Tsiligianni (IT) has received honoraria for educational activities, speaking engagements and advisory boards from Boehringer Ingelheim, Novartis, AstraZeneca and GlaxoSmithKline. Christine Jenkins (CJ) reports personal fees from Novartis Pharma AG, during the conduct of the study; grants and personal fees from GlaxoSmithKline, personal fees from AstraZeneca, Boehringer Ingelheim, Menarini, outside the submitted work. Robert Fogel (RF), Sebastian Fucile (SF), Steven Shen (SS), Pankaj Goyal (PG), Karen Mezzi (KM) are employees and shareholders of the analysis sponsor, Novartis. Konstantinos Kostikas (KK) was an employee of Novartis Pharma AG at the time of the conduct of this study. None of the authors received any compensation for the development of the manuscript.
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