{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T19:16:26Z","timestamp":1780514186988,"version":"3.54.1"},"reference-count":42,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T00:00:00Z","timestamp":1709164800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T00:00:00Z","timestamp":1709164800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Pharmacokinet"],"published-print":{"date-parts":[[2024,4]]},"DOI":"10.1007\/s40262-024-01352-9","type":"journal-article","created":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T20:02:01Z","timestamp":1709236921000},"page":"483-496","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Clinical Evaluation of the Effect of Encorafenib on Bupropion, Rosuvastatin, and Coproporphyrin I and Considerations for Statin Coadministration"],"prefix":"10.1007","volume":"63","clinical-trial-number":[{"clinical-trial-number":"nct03864042","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-1174-966X","authenticated-orcid":false,"given":"Joseph","family":"Piscitelli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micaela B.","family":"Reddy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lance","family":"Wollenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence","family":"Del Frari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Gong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Wood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yizhong","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyle","family":"Matschke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason H.","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,2,29]]},"reference":[{"key":"1352_CR1","unstructured":"Braftovi (encorafenib) capsules, Full Prescribing Information. <https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2018\/210496Orig1s000MultidisciplineR.pdf.US. Accessed 3 Aug 2023."},{"key":"1352_CR2","unstructured":"Food and Drug Administration. Immunogenicity testing of therapeutic protein products \u2014developing and validating assays for anti-drug antibody detection Guidance for Industry. 2019. https:\/\/www.fda.gov\/media\/119788\/download. Accessed 13 Nov 2023."},{"key":"1352_CR3","unstructured":"European Medicines Agency ICH Guideline M12. Drug Interaction Studies. 2022 https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/draft-ich-guideline-m12-drug-interaction-studies-step-2b_en.pdf. Accessed 3 Aug 2023."},{"key":"1352_CR4","unstructured":"BRAFTOVI (encorafenib) capsules, prescribing information. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/210496s013lbl.pdf. Accessed 3 Aug 2023."},{"issue":"18","key":"1352_CR5","doi-asserted-by":"publisher","first-page":"5339","DOI":"10.1158\/1078-0432.CCR-16-2923","volume":"23","author":"JP Delord","year":"2017","unstructured":"Delord JP, Robert C, Nyakas M, McArthur GA, Kudchakar R, Mahipal A, et al. Phase I dose-escalation and -expansion study of the BRAF inhibitor encorafenib (LGX818) in metastatic BRAF-mutant melanoma. Clin Cancer Res. 2017;23(18):5339\u201348.","journal-title":"Clin Cancer Res"},{"issue":"19","key":"1352_CR6","doi-asserted-by":"publisher","first-page":"2375","DOI":"10.1200\/JCO.2011.41.1660","volume":"30","author":"L Zimmer","year":"2012","unstructured":"Zimmer L, Hillen U, Livingstone E, Lacouture ME, Busam K, Carvajal RD, et al. Atypical melanocytic proliferations and new primary melanomas in patients with advanced melanoma undergoing selective BRAF inhibition. J Clin Oncol. 2012;30(19):2375\u201383.","journal-title":"J Clin Oncol"},{"key":"1352_CR7","unstructured":"MEKTOVI (binimetinib) tablets, Full prescribing information. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/210498s001lbl.pdf. Accessed 3 Aug 2023."},{"issue":"6","key":"1352_CR8","doi-asserted-by":"publisher","first-page":"565","DOI":"10.1016\/j.clpt.2006.09.003","volume":"80","author":"PJ Neuvonen","year":"2006","unstructured":"Neuvonen PJ, Niemi M, Backman JT. Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance. Clin Pharmacol Ther. 2006;80(6):565\u201381.","journal-title":"Clin Pharmacol Ther"},{"issue":"3","key":"1352_CR9","doi-asserted-by":"publisher","first-page":"277","DOI":"10.2478\/acph-2013-0022","volume":"63","author":"A Causevic-Ramosevac","year":"2013","unstructured":"Causevic-Ramosevac A, Semiz S. Drug interactions with statins. Acta Pharm. 2013;63(3):277\u201393.","journal-title":"Acta Pharm"},{"issue":"1","key":"1352_CR10","doi-asserted-by":"publisher","first-page":"25","DOI":"10.2174\/1872312813666181129101507","volume":"13","author":"LW Han","year":"2019","unstructured":"Han LW, Gao C, Zhang Y, Wang J, Mao Q. Transport of bupropion and its metabolites by the model CHO and HEK293 cell lines. Drug Metab Lett. 2019;13(1):25\u201336.","journal-title":"Drug Metab Lett"},{"key":"1352_CR11","unstructured":"Wellbutrin (bupropion hydrochloride) tablets, full prescribing information. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/018644s043lbl.pdf. Accessed 3 Aug 2023."},{"issue":"10","key":"1352_CR12","first-page":"1222","volume":"28","author":"SR Faucette","year":"2000","unstructured":"Faucette SR, Hawke RL, Lecluyse EL, Shord SS, Yan B, Laethem RM, et al. Validation of bupropion hydroxylation as a selective marker of human cytochrome P450 2B6 catalytic activity. Drug Metab Dispos. 2000;28(10):1222\u201330.","journal-title":"Drug Metab Dispos"},{"key":"1352_CR13","unstructured":"US Food and Drug Administration. Drug development and drug interactions: table of substrates, inhibitors and inducers. https:\/\/www.fda.gov\/drugs\/drug-interactions-labeling\/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Accessed 3 Aug 2023."},{"issue":"17","key":"1352_CR14","doi-asserted-by":"publisher","first-page":"1632","DOI":"10.1056\/NEJMoa1908075","volume":"381","author":"S Kopetz","year":"2019","unstructured":"Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, et al. Encorafenib, binimetinib, and cetuximab in BRAF V600E-mutated colorectal cancer. N Engl J Med. 2019;381(17):1632\u201343.","journal-title":"N Engl J Med"},{"issue":"3","key":"1352_CR15","doi-asserted-by":"publisher","first-page":"564","DOI":"10.1002\/cpt.983","volume":"104","author":"S Barnett","year":"2018","unstructured":"Barnett S, Ogungbenro K, Menochet K, Shen H, Lai Y, Humphreys WG, et al. Gaining mechanistic insight into coproporphyrin i as endogenous biomarker for OATP1B-mediated drug-drug interactions using population pharmacokinetic modeling and simulation. Clin Pharmacol Ther. 2018;104(3):564\u201374.","journal-title":"Clin Pharmacol Ther"},{"issue":"1","key":"1352_CR16","doi-asserted-by":"publisher","first-page":"269","DOI":"10.1002\/cpt.1599","volume":"107","author":"NS Jones","year":"2020","unstructured":"Jones NS, Yoshida K, Salphati L, Kenny JR, Durk MR, Chinn LW. Complex DDI by fenebrutinib and the use of transporter endogenous biomarkers to elucidate the mechanism of DDI. Clin Pharmacol Ther. 2020;107(1):269\u201377.","journal-title":"Clin Pharmacol Ther"},{"issue":"8","key":"1352_CR17","doi-asserted-by":"publisher","first-page":"517","DOI":"10.1002\/psp4.12315","volume":"7","author":"K Yoshida","year":"2018","unstructured":"Yoshida K, Guo C, Sane R. Quantitative prediction of OATP-Mediated drug-drug interactions with model-based analysis of endogenous biomarker kinetics. CPT Pharmacometrics Syst Pharmacol. 2018;7(8):517\u201324.","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"issue":"3","key":"1352_CR18","doi-asserted-by":"publisher","first-page":"259","DOI":"10.1002\/cpt.406","volume":"100","author":"P Stopfer","year":"2016","unstructured":"Stopfer P, Giessmann T, Hohl K, Sharma A, Ishiguro N, Taub ME, et al. Pharmacokinetic evaluation of a drug transporter cocktail consisting of digoxin, furosemide, metformin, and rosuvastatin. Clin Pharmacol Ther. 2016;100(3):259\u201367.","journal-title":"Clin Pharmacol Ther"},{"issue":"17","key":"1352_CR19","doi-asserted-by":"publisher","first-page":"1460","DOI":"10.1200\/JCO.18.02459","volume":"37","author":"E Van Cutsem","year":"2019","unstructured":"Van Cutsem E, Huijberts S, Grothey A, Yaeger R, Cuyle PJ, Elez E, et al. Binimetinib, encorafenib, and cetuximab triplet therapy for patients with BRAF V600E-mutant metastatic colorectal cancer: safety lead-in results from the phase III BEACON colorectal cancer study. J Clin Oncol. 2019;37(17):1460\u20139.","journal-title":"J Clin Oncol"},{"issue":"3","key":"1352_CR20","doi-asserted-by":"publisher","first-page":"349","DOI":"10.1038\/clpt.2014.83","volume":"96","author":"M Bosilkovska","year":"2014","unstructured":"Bosilkovska M, Samer CF, Deglon J, Rebsamen M, Staub C, Dayer P, et al. Geneva cocktail for cytochrome p450 and P-glycoprotein activity assessment using dried blood spots. Clin Pharmacol Ther. 2014;96(3):349\u201359.","journal-title":"Clin Pharmacol Ther"},{"issue":"19","key":"1352_CR21","doi-asserted-by":"publisher","first-page":"5102","DOI":"10.1158\/1078-0432.CCR-19-3550","volume":"26","author":"RJ Sullivan","year":"2020","unstructured":"Sullivan RJ, Weber J, Patel S, Dummer R, Carlino MS, Tan DSW, et al. A Phase Ib\/II study of the BRAF inhibitor encorafenib plus the MEK inhibitor binimetinib in patients with BRAF(V600E\/K) -mutant solid tumors. Clin Cancer Res. 2020;26(19):5102\u201312.","journal-title":"Clin Cancer Res"},{"issue":"2","key":"1352_CR22","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1007\/s40262-020-00978-9","volume":"60","author":"R Kanukula","year":"2021","unstructured":"Kanukula R, Salam A, Rodgers A, Kamel B. Pharmacokinetics of rosuvastatin: a systematic review of randomised controlled trials in healthy adults. Clin Pharmacokinet. 2021;60(2):165\u201375.","journal-title":"Clin Pharmacokinet"},{"issue":"5","key":"1352_CR23","doi-asserted-by":"publisher","first-page":"1513","DOI":"10.1208\/s12248-017-0102-8","volume":"19","author":"JN Connarn","year":"2017","unstructured":"Connarn JN, Flowers S, Kelly M, Luo R, Ward KM, Harrington G, et al. Pharmacokinetics and pharmacogenomics of bupropion in three different formulations with different release kinetics in healthy human volunteers. AAPS J. 2017;19(5):1513\u201322.","journal-title":"AAPS J"},{"issue":"1","key":"1352_CR24","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1038\/clpt.2013.12","volume":"94","author":"KM Giacomini","year":"2013","unstructured":"Giacomini KM, Balimane PV, Cho SK, Eadon M, Edeki T, Hillgren KM, et al. International Transporter Consortium commentary on clinically important transporter polymorphisms. Clin Pharmacol Ther. 2013;94(1):23\u20136.","journal-title":"Clin Pharmacol Ther"},{"issue":"4","key":"1352_CR25","doi-asserted-by":"publisher","first-page":"726","DOI":"10.1002\/cpt.1477","volume":"106","author":"Z Desta","year":"2019","unstructured":"Desta Z, Gammal RS, Gong L, Whirl-Carrillo M, Gaur AH, Sukasem C, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2B6 and efavirenz-containing antiretroviral therapy. Clin Pharmacol Ther. 2019;106(4):726\u201333.","journal-title":"Clin Pharmacol Ther"},{"issue":"1","key":"1352_CR26","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1002\/phar.2644","volume":"42","author":"S Eum","year":"2022","unstructured":"Eum S, Sayre F, Lee AM, Stingl JC, Bishop JR. Association of CYP2B6 genetic polymorphisms with bupropion and hydroxybupropion exposure: a systematic review and meta-analysis. Pharmacotherapy. 2022;42(1):34\u201344.","journal-title":"Pharmacotherapy"},{"key":"1352_CR27","unstructured":"Piscitelli J, Rashid J, Zhang Y, Williams J. Extension to Coproporphyrin I (CP-I) compartmental models to explore unique patterns in cancer patients supporting prediction of OATP1B1 Inhibition. In: 13th Annual American Conference on pharmacometrics. 2022."},{"issue":"10","key":"1352_CR28","doi-asserted-by":"publisher","first-page":"1720","DOI":"10.1124\/dmd.116.071076","volume":"44","author":"OA Fahmi","year":"2016","unstructured":"Fahmi OA, Shebley M, Palamanda J, Sinz MW, Ramsden D, Einolf HJ, et al. Evaluation of CYP2B6 induction and prediction of clinical drug-drug interactions: considerations from the IQ Consortium Induction Working Group-an industry perspective. Drug Metab Dispos. 2016;44(10):1720\u201330.","journal-title":"Drug Metab Dispos"},{"issue":"5","key":"1352_CR29","doi-asserted-by":"publisher","first-page":"327","DOI":"10.1097\/00004714-199510000-00004","volume":"15","author":"TA Ketter","year":"1995","unstructured":"Ketter TA, Jenkins JB, Schroeder DH, Pazzaglia PJ, Marangell LB, George MS, et al. Carbamazepine but not valproate induces bupropion metabolism. J Clin Psychopharmacol. 1995;15(5):327\u201333.","journal-title":"J Clin Psychopharmacol"},{"key":"1352_CR30","unstructured":"Encorafenib Summary of Product Characteristics. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/braftovi-epar-product-information_en.pdf. Accessed 3 Aug 2023."},{"issue":"4","key":"1352_CR31","doi-asserted-by":"publisher","first-page":"859","DOI":"10.1016\/S1734-1140(11)70601-6","volume":"63","author":"M Tomaszewski","year":"2011","unstructured":"Tomaszewski M, Stepien KM, Tomaszewska J, Czuczwar SJ. Statin-induced myopathies. Pharmacol Rep. 2011;63(4):859\u201366.","journal-title":"Pharmacol Rep"},{"issue":"6","key":"1352_CR32","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1007\/s10557-005-5686-z","volume":"19","author":"E Bruckert","year":"2005","unstructured":"Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients\u2013the PRIMO study. Cardiovasc Drugs Ther. 2005;19(6):403\u201314.","journal-title":"Cardiovasc Drugs Ther"},{"issue":"1","key":"1352_CR33","doi-asserted-by":"publisher","first-page":"101","DOI":"10.1038\/clpt.2014.66","volume":"96","author":"R Vargo","year":"2014","unstructured":"Vargo R, Adewale A, Behm MO, Mandema J, Kerbusch T. Prediction of clinical irrelevance of PK differences in atorvastatin using PK\/PD models derived from literature-based meta-analyses. Clin Pharmacol Ther. 2014;96(1):101\u20139.","journal-title":"Clin Pharmacol Ther"},{"issue":"3 Suppl","key":"1352_CR34","doi-asserted-by":"publisher","first-page":"S30","DOI":"10.1016\/j.jacl.2014.02.010","volume":"8","author":"KA Kellick","year":"2014","unstructured":"Kellick KA, Bottorff M, Toth PP. A clinician\u2019s guide to statin drug-drug interactions. J Clin Lipidol. 2014;8(3 Suppl):S30-46.","journal-title":"J Clin Lipidol"},{"issue":"1","key":"1352_CR35","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1208\/s12248-014-9668-6","volume":"17","author":"Q Mao","year":"2015","unstructured":"Mao Q, Unadkat JD. Role of the breast cancer resistance protein (BCRP\/ABCG2) in drug transport\u2013an update. AAPS J. 2015;17(1):65\u201382.","journal-title":"AAPS J"},{"issue":"3","key":"1352_CR36","doi-asserted-by":"publisher","first-page":"398","DOI":"10.1124\/dmd.115.066795","volume":"44","author":"R Elsby","year":"2016","unstructured":"Elsby R, Martin P, Surry D, Sharma P, Fenner K. Solitary Inhibition of the breast cancer resistance protein efflux transporter results in a clinically significant drug-drug interaction with rosuvastatin by causing up to a 2-fold increase in statin exposure. Drug Metab Dispos. 2016;44(3):398\u2013408.","journal-title":"Drug Metab Dispos"},{"issue":"3","key":"1352_CR37","doi-asserted-by":"publisher","first-page":"397","DOI":"10.1124\/jpet.116.234914","volume":"358","author":"Y Lai","year":"2016","unstructured":"Lai Y, Mandlekar S, Shen H, Holenarsipur VK, Langish R, Rajanna P, et al. Coproporphyrins in plasma and urine can be appropriate clinical biomarkers to recapitulate drug-drug interactions mediated by organic anion transporting polypeptide inhibition. J Pharmacol Exp Ther. 2016;358(3):397\u2013404.","journal-title":"J Pharmacol Exp Ther"},{"issue":"12","key":"1352_CR38","doi-asserted-by":"publisher","first-page":"1559","DOI":"10.1007\/s40262-018-0648-3","volume":"57","author":"A Kunze","year":"2018","unstructured":"Kunze A, Ediage EN, Dillen L, Monshouwer M, Snoeys J. clinical investigation of coproporphyrins as sensitive biomarkers to predict mild to strong OATP1B-mediated drug-drug interactions. Clin Pharmacokinet. 2018;57(12):1559\u201370.","journal-title":"Clin Pharmacokinet"},{"issue":"1","key":"1352_CR39","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1002\/psp4.12571","volume":"10","author":"CM Bowman","year":"2021","unstructured":"Bowman CM, Ma F, Mao J, Chen Y. Examination of physiologically-based pharmacokinetic models of rosuvastatin. CPT Pharmacometrics Syst Pharmacol. 2021;10(1):5\u201317.","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"issue":"4","key":"1352_CR40","doi-asserted-by":"publisher","first-page":"689","DOI":"10.1007\/s13318-016-0383-9","volume":"42","author":"P Duan","year":"2017","unstructured":"Duan P, Zhao P, Zhang L. Physiologically based pharmacokinetic (PBPK) modeling of pitavastatin and atorvastatin to predict drug-drug interactions (DDIs). Eur J Drug Metab Pharmacokinet. 2017;42(4):689\u2013705.","journal-title":"Eur J Drug Metab Pharmacokinet"},{"issue":"5","key":"1352_CR41","doi-asserted-by":"publisher","first-page":"1082","DOI":"10.1002\/cpt.1693","volume":"107","author":"KS Taskar","year":"2020","unstructured":"Taskar KS, Pilla Reddy V, Burt H, Posada MM, Varma M, Zheng M, et al. Physiologically-based pharmacokinetic models for evaluating membrane transporter mediated drug-drug interactions: current capabilities, case studies, future opportunities, and recommendations. Clin Pharmacol Ther. 2020;107(5):1082\u2013115.","journal-title":"Clin Pharmacol Ther"},{"issue":"36","key":"1352_CR42","doi-asserted-by":"publisher","first-page":"4178","DOI":"10.1200\/JCO.21.02659","volume":"40","author":"R Dummer","year":"2022","unstructured":"Dummer R, Flaherty KT, Robert C, Arance A, de Groot JWB, Garbe C, et al. COLUMBUS 5-year update: a randomized, open-label, phase iii trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF V600-mutant melanoma. J Clin Oncol. 2022;40(36):4178\u201388.","journal-title":"J Clin Oncol"}],"container-title":["Clinical Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-024-01352-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40262-024-01352-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-024-01352-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,26]],"date-time":"2024-04-26T09:11:27Z","timestamp":1714122687000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40262-024-01352-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,29]]},"references-count":42,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["1352"],"URL":"https:\/\/doi.org\/10.1007\/s40262-024-01352-9","relation":{},"ISSN":["0312-5963","1179-1926"],"issn-type":[{"value":"0312-5963","type":"print"},{"value":"1179-1926","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,29]]},"assertion":[{"value":"30 January 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 February 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This work was sponsored by Pfizer.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"J.P., M.B.R., L.W., J.G., L.W., Y.Z., K.M., and J.H.W. are employees of Pfizer and hold Pfizer stock. L.D.F. is an employee of Pierre Fabre Medicament.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See  for more information.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"These studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, particularly those affording greater protection to the safety of trial participants. An institutional review board approved the protocols, and all participants gave written informed consent. This trial was registered on ClinicalTrials.gov: NCT03864042.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All participants provided written informed consent before undergoing any study procedures.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"JP, MBR, LW, LDF, JG, LW, YZ, KM, and JHW designed and performed the research, analyzed the data, and wrote the manuscript.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}