1134-8046 1134-8046 S1134-80462020000100011 10.20986/resed.2018.3645/2017 España 00 02 2020 00 02 2020 27 1 61 62 1 2013 309 7 7 657-9 2 Center for Drug Evaluation and Research (CDER) 2015 3 2015 72 5 5 424-30 4 2017 13 6 6 353-6 5 2017 13 6 6 363-4 6 2017 13 6 6 365-77 7 2016 6 5 5 497-508