Received: 13 February 2018
Accepted: 19 February 2019
First Online: 28 February 2019
Ethics approval and consent to participate
: This study was exempt from review by an institutional review board because the database was compliant with the Health Insurance Portability and Accountability Act and because the data do not include any identifiable patient information. The data used for this study did not involve the interaction or interview with any subjects and the data does not include any individually identifiable data (e.g. does not include names, addresses, social security or medical record numbers or other obvious identifiers) and as such is not research involving human subject as defined at 45 CFR 46.102(f)(2). Furthermore, this study used existing fully de-identified and the investigator(s) cannot be identified, directly or through identifiers linked to subjects and as such is exempt from 45 CFR 46.101(b)(4) from all 45 CFR part 46 requirements.
: Not applicable.
: MSA, RS, and RAB are employees of Otsuka America Pharmaceuticals, Inc. AH is an employee of Lundbeck. HF received consulting fees from Lundbeck. Research and editorial support were funded by Otsuka America Pharmaceutical, Inc., Princeton, NJ, USA.
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