Hirata, Koichi
Ueda, Kaname
Ye, Wenyu
Kim, Yongin
Komori, Mika
Jackson, James
Cotton, Sarah
Rajan, Narayan
Treuer, Tamas
Funding for this research was provided by:
Eli Lilly and Company (N/A)
Article History
Received: 25 November 2019
Accepted: 29 June 2020
First Online: 8 July 2020
Ethics approval and consent to participate
: Disease Specific Programme (DSP) data were collected in accordance with Adelphi Real World procedures, which are compliant with the Health Information Technology for Economic and Clinical Health (HITECH) Act and the Health Insurance Portability and Accountability Act (HIPAA). As a matter of routine, Adelphi Real World establishes a Master Services Agreement with each fieldwork partner. This includes the conditions that agencies have to follow local guidelines in addition to adhering to the European Pharmaceutical Market Research Association (EphMRA) Code of Conduct and allows for circumstances where local regulations may be different to (more stringent than) EphMRA guidelines. As this was a retrospective analysis that used deidentified data that had been previously collected, patient participants were not required to provide formal Consent to Release Information forms for the current analyses; the original consent from those who provided data in the DSP covered the planned analyses in this study.
: Not applicable.
: KH reports grants from the Ministry of Health, Labor and Welfare, grants from The Japan Agency for Medical Research and Development, and non-financial support from Alexion Pharmaceuticals, Inc., during the conduct of the study. KU, WY, YK, MK, NR and TT are full-time employees and minor stock-holders of Eli Lilly and Company. SC and JJ are full-time employees of Adelphi Real World.