Hunt, Thomas L.
Tzanis, Evan
Bai, Stephen
Manley, Amy
Chitra, Surya
McGovern, Paul C.
Funding for this research was provided by:
Paratek Pharmaceuticals, Inc
Article History
First Online: 12 November 2020
Declarations
:
: This work was funded by Paratek Pharmaceuticals, Inc., King of Prussia, PA. Medical writing and editorial assistance was provided by Theresa Singleton, PhD, and Linda Edmondson of Innovative Strategic Communications, LLC, which was funded by Paratek Pharmaceuticals, Inc.
: Open access publication of this manuscript was sponsored by Paratek Pharmaceuticals, Inc.
: A.M. is an employee of Paratek Pharmaceuticals, Inc. P.C.M. is a former employee of, has received consulting fees from, and is a shareholder of Paratek Pharmaceuticals, Inc. E.T. is a former employee and current shareholder of Paratek Pharmaceuticals, Inc. S.B. is a consultant to Paratek Pharmaceuticals Inc. in matters relating to clinical pharmacology and/or drug disposition, including pharmacokinetics, aspects in study design, and data interpretation. S.C. is a consultant to Paratek Pharmaceuticals Inc. T.L.H. has no conflicts of interest to declare.
: Written and signed informed consent was obtained from each study participant before any protocol-specific assessment was performed.
: Not applicable; patient level data are not included in this manuscript.
: Not-applicable.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board or independent ethics committee for each study center, and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Written and signed informed consent was obtained from each study participant before any protocol-specific assessment was performed. The study was described by investigators and written information was given to each participant.
: Paratek Pharmaceuticals has a commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants, when permitted, feasible and appropriate. Requests for de-identified patient-level data may be submitted to medinfo@paratekpharma.com for review. Datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. The Food and Drug Administration 2019 Advisory Committee report on omadacycline can be accessed here:ExternalRef removed.