Disclosure of potential conflict of interest
OAC has received research grants from Actelion, Arsanis, Astellas, AstraZeneca, Basilea, Bayer, Cidara, Duke University, F2G, Gilead, GSK, Leeds University, Medicines Company, MedPace, Melinta Therapeutics, Merck/MSD, Miltenyi, Pfizer, Rempex, Roche, Sanofi Pasteur, Scynexis, Seres Therapeutics and The Medicines Company; and personal fees from Actelion, Amplyx, Astellas, Basilea, Cidara, Da Volterra, F2G, Gilead, IQVIA, Janssen Pharmaceuticals, Matinas, Menarini Ricerche, Merck/MSD, Paratek Pharmaceuticals, Pfizer, PSI, Scynexis, Seres Therapeutics, Summit, Tetraphase and Vical.
MJGTV is a consultant to Astellas Pharma, Berlin Chemie, MaaT Pharma and MSD/Merck; has served at the speakers’ bureaux of Astellas Pharma, Basilea, Falk Foundation, Gilead Sciences, Merck/MSD, Organobalance and Pfizer and received research funding from 3M, Astellas Pharma, DaVolterra, Gilead Sciences, Merck/MSD, Morphochem, Organobalance and Seres Therapeutics.
NA was an employee of Astellas Pharma, Inc. during the conduct of the study.
AG is a full-time employee of Astellas Pharma Europe Ltd.
AK is a full-time employee of Astellas Pharma Ltd. and has patents WO2015169451 A1 and EP17167541.6 pending to Astellas Pharma Europe Ltd.
GK is a consultant statistician for Astellas Pharma, Inc.
BG received personal and institutional fees from Astellas Pharma, Pfizer and MSD, non-financial support from Astellas Pharma and research grants from Combioxin and Fondation Santos Suarez.
Ethical approval
The study was conducted in accordance with local ethical committees’ regulations, the Declaration of Helsinki, and the International Council of Harmonisation Good Clinical Practice guidelines.
Informed consent
Patients provided written informed consent and could withdraw from the study at any time.