Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain: A Randomized Noninferiority Phase 3 Trial.

"Supported by Yuhan Corporation (Seoul, Republic of Korea), which was involved in all aspects of study design, data collection, data analysis, data interpretation, assisted in writing the report, and approved the final version of the manuscript for publication in conjunction with the authors. S.K. and T.A. are employees of Yuhan Corporation, Seoul, Republic of Korea. The remaining authors declare no conflict of interest."

"Supported by Yuhan Corporation (Seoul, Republic of Korea), which was involved in all aspects of study design, data collection, data analysis, data interpretation, assisted in writing the report, and approved the final version of the manuscript for publication in conjunction with the authors. S.K. and T.A. are employees of Yuhan Corporation, Seoul, Republic of Korea. The remaining authors declare no conflict of interest."

"This was a randomized, double-blind, active-controlled, multicenter, phase 3 study conducted at 41 sites in South Korea between February 2017 and May 2018. The institutional review board at each site reviewed and approved the study protocol and other relevant documents before study initiation. The study was conducted in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice of the International Conference for Harmonisation, and the applicable local laws and regulations. All patients provided written informed consent before any study-related procedures were performed. This study was registered at ClinicalTrials.gov (identifier NCT02985216)."