Doty, Richard L.
Popova, Vanina http://orcid.org/0000-0002-9687-2238
Wylie, Crystal
Fedgchin, Maggie
Daly, Ella
Janik, Adam
Ochs-Ross, Rachel
Lane, Rosanne
Lim, Pilar
Cooper, Kim
Melkote, Rama
Jamieson, Carol
Singh, Jaskaran
Drevets, Wayne C.
Funding for this research was provided by:
Janssen Research & Development, LLC
Article History
Accepted: 4 May 2021
First Online: 7 July 2021
Declarations
:
: The studies presented in this report were supported by Janssen Research & Development, LLC, USA. Open access funding was provided by Janssen Research & Development, LLC, USA.
: All the authors, except Dr. Doty, Ms. Wylie and Dr. Singh, are employees of Janssen Research & Development, LLC and shareholders of Johnson & Johnson. Dr. Doty is President and major shareholder of Sensonics International, the manufacturer and distributor of smell and taste tests, including the tests used in these studies. He is a consultant to Acorda Therapeutics, Eisai Co., Ltd., Merck Pharmaceuticals, The Michael J. Fox Foundation for Parkinson’s Research, and Johnsons & Johnson. He receives royalties from Cambridge University Press, Johns Hopkins University Press, and John Wiley & Sons, Inc. Ms Wylie was employed at Sensonics International and the Smell and Taste Center at the Hospital of University of Pennsylvania when this study was conducted. Jaskaran Singh worked on the clinical development program of esketamine for treatment-resistant depression during his employment by Janssen Research & Development, LLC; he is currently employed by Neurocrine Biosciences, San Diego, CA.
: The protocol and informed consent forms were approved by local independent ethics committees/Institutional Review Boards. All procedures performed in studies involving human participants were in accordance with the International Council for Harmonisation Good Clinical Practice Consolidated Guideline, the applicable local laws and regulatory requirements of the countries in which the trial was conducted, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Written informed consent/assent was obtained from all individual patients included in the trial (or their parent/legal representative) before any trial-specific procedures were performed or any patient-related data were collected.
: Not applicable.
: All data generated or analyzed during this study are included in this published article and its supplementary information files. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at ExternalRef removed. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access [YODA] Project site at ExternalRef removed.
: Conception and design: MF, VP, ED, JS, RO-R. Collection and assembly of data: MD and CW, MF, VP. Data analysis and interpretation: RLD. All authors participated in supervising recruitment, monitoring of data quality, and development and review of this manuscript and confirm that they have read the journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. All authors meet ICMJE criteria and all those who fulfilled those criteria are listed as authors. All authors had access to the study data, provided direction and comments on the manuscript, made the final decision about where to publish these data and approved submission to this journal.