Inoue, Satoru
Vaidya, Soniya
Tillmann, Hanns-Christian
Sakita, Yohei
Machineni, Surendra
Heudi, Olivier
Furihata, Kenichi
Funding for this research was provided by:
Novartis Pharma AG
Article History
Received: 19 February 2020
Accepted: 16 September 2020
First Online: 7 January 2021
Ethics approval and consent to participate
: The study was conducted in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization Guideline for Good Clinical Practice, and the Japanese Standards for the Implementation of Clinical Trials on Pharmaceutical Product. The study protocol was reviewed and approved by the Institutional Review Board of P-one clinic<b>.</b> Informed consent was obtained from each subject in writing before any screening procedures were performed.
: Informed consent was obtained from each subject in writing before any screening procedures were performed.
: SI, SV, HCT, YS, SM and OH were employees of Novartis at the time of study completion.