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Article History

Received: 23 March 2021

Accepted: 25 June 2021

First Online: 25 September 2021

Declarations

:

: The COAST-X trial was conducted in accordance with the standards of the Declaration of Helsinki and Good Clinical Practice Guidelines (CPMP/ICH/135/95). The master ethics committee was Schulman Associates IRB, Cincinnati, OH, USA. All patients gave written informed consent before trial start.

: Not applicable.

: AD has received consulting fees from and has served on the advisory boards of AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, and UCB as well as receiving research grants from AbbVie, Eli Lilly, Glaxo Smith & Kline, Novartis, Pfizer, and UCB. PM has received research grants, consulting fees, and/or speaker fees from Abbvie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. HMO has received grant or research support from Janssen and Novartis, has received consulting fees from AbbVie, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, and UCB, and has received speaker fees from AbbVie, Biogen, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, Takeda, and UCB. TH, DS, AK, and SL are employees and shareholders of Eli Lilly and Company. AL is an employee of Syneos Health, vendor of Eli Lilly and Company. Victoria Navarro-Compán has consulting fees, speaker fees, and research grants from Abbvie, Bristol Myers Squibb, Janssen, Eli Lilly and Company, MSD, Novartis, Pfizer, Roche, and UCB.