Funding for this research was provided by:
Accepted: 5 December 2020
First Online: 12 January 2021
: The studies described in this article were funded by Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company.
: David M. Pariser was an investigator and consultant for Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company, and received writing assistance. Edward L. Lain has received payment from the sponsor for work as a principal investigator, advisory board member, speaker, and consultant, but did not receive compensation for work related to the preparation and publication of this article. Richard D. Mamelok is a paid consultant to Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company, and received financial support for reviewing data and for reviewing the manuscript. Janice Drew is a full-time employee and receives a salary from the sponsor of the study, Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company. Diane R. Mould is the president of Projections Research Inc., a consulting company for the pharmaceutical industry and was a paid consultant of Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company for the conduct of the data analysis.
: For the phase I and II clinical studies described in the article, the protocols, informed consent forms, and assent forms for subjects under legal adult age (phase I study only) were submitted to an institutional review board or independent ethics committee for review and approval before the start of the study. The studies were conducted in compliance with the principles of the International Conference on Harmonisation (E6 1997) Good Clinical Practice, US Food and Drug Administration guidelines, and the Declaration of Helsinki, 1964 (as amended in Edinburgh ).
: For the phase I and II clinical studies described in the article, informed consent was obtained.
: All authors consent to the publication of the article.
: Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company, shares data related to these trials in peer-reviewed journals, medical congresses, and ClinicalTrials.gov. Individual patient data are not publicly available.
: Not applicable.
: JD, DRM, and RDM had access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. JD, DRM, and RDM provided the concept and design for the study. All authors were responsible for the acquisition, analysis, or interpretation of the data and the drafting and critical revision of the manuscript for important intellectual content. DRM and RDM conducted the data analysis.