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US Food and Drug Administration, Silver Spring, Md.
Warning: The opinions expressed are those of the authors and do not necessarily represent the position of the FDA or the US Government nor imply their endorsement.
Disclosures: The authors did not reveal any conflict of interest. The forms can be found at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0085.
Disclosures of the editors: Christine Laine, MD, MPH, editor-in-chief, says his wife holds stock / asset purchase options with targeted diagnoses and therapies. Darren B. Taichman, MD, PhD, editor, says that he has no financial relationship and no interest in disclosing. Cynthia D. Mulrow, MD, MSc, Senior Editor, says she has no relationship or interest in disclosing. Jaya K. Rao, MD, MHS, Associate Editor, says she has stock / stock options at Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, associate chief statistics editor, says she owns shares in Pfizer, Johnson & Johnson and Colgate-Palmolive. Christina C. Wee, MD, MPH, Associate Editor, reports a job at Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, deputy editor, says that he has no financial relationship and no interest in disclosing. Yu-Xiao Yang, MD, MSCE, deputy editor, says that he has no financial relationship nor any interest in disclosing.
Repeatable Research Statement:Study protocol: See Methods. Statistical code: Not applicable. Dataset: Unavailable.
Corresponding author: Susan J. Bersoff-Matcha, MD, CDER / OMP / DCTQ, White Oak, Building 51, Room 3355, 10903 New Hampshire Avenue, Silver Spring, MD 20993; email, [email protected].
Address of the current author: Dr. Bersoff-Matcha: CDER / OMP / DCTQ, White Oak, Building 51, Room 3355, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Dr. Chamberlain: CDER / OSE / DPVI, White Oak, Building 22, Room 3492, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Mr. Cao: CDER / OSE / DPVI, White Oak, Building 22, Room 3468, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Dr. Kortepeter: CDER / OSE / DPVI, White Oak, Building 22, Room 3496, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Dr. Chong: CDER / OND / DMEP, White Oak, Building 22, Room 3346, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Author contributions: Design and Design: S.J. Bersoff-Matcha, C. Chamberlain, C. Cao, C. Kortepeter.
Data Analysis and Interpretation: S.J. Bersoff-Matcha, C. Chamberlain, C. Cao, W.H. Chong.
Article Writing: S.J. Bersoff-Matcha, C. Chamberlain, C. Cao.
Critical Review of Important Intellectual Content: S.J. Bersoff-Matcha, C. Chamberlain, C. Cao, W.H. Chong.
Final approval of the article: S.J. Bersoff-Matcha, C. Chamberlain, C. Cao, C. Kortepeter, W.H. Chong.
Administrative, technical or logistical assistance: S.J. Bersoff-Matcha, C. Chamberlain.
Collecting and Assembling Data: S.J. Bersoff-Matcha, C. Chamberlain, C. Cao.
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