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Article History

Received: 19 November 2019

Accepted: 18 December 2019

First Online: 26 December 2019

Ethics approval and consent to participate

: This trial was performed in accordance with ethical principles consistent with the Declaration of Helsinki, International Conference on Harmonisation (ICH) guidelines, International Society for Pharmacoepidemiology (ISPE) (2007) Guidelines for Good Pharmacoepidemiology Practices (GPP) and applicable legislation. The Investigator(s) have performed this trial in accordance with the regulations and guidelines governing medical practice and ethics in the countries of the trial and in accordance with currently acceptable techniques and know-how. The final protocol of this trial, including the final version of the subject or next of kin/legal representative ICF, was approved or given a favorable opinion in writing by the Ethics Committee/Institutional Review Board (IRB)/Independent Ethics Committee (IEC). The Ethics Committee/IRB/IEC also approved any amendments to the protocol and all communication to patient or next of kin, according to local regulations.

: Not applicable.

: SIP has served as a consultant or in an advisory role for AbbVie, AstraZeneca/MedImmune, Cue, EMD Serono, Merck, Newlink Genetics, Oncolys, Replimune, and Sensei; has received research funding for Abbvie, AstraZeneca/MedImmune, Cue, Merck, Tesaro; and received compensation for travel, accommodations and/or expenses from AbbVie, AstraZeneca/MedImmune, EMD Serono, Newlink Genetics, Oncolys, and Sensei. EEWC has been a consultant or held an advisory role for AstraZeneca, Bristol-Myers Squibb, EMD Serono, Human Longevity, Inc, Merck, Pfizer. GF has received honoraria from AstraZeneca; and served as a consutant or in an advisory role for Boehringer Ingelheim, Celgene, and Lilly. ESK has received honoraria from AstraZeneca, Boehringer Ingelheim, Celgene, and Lilly; has served as a consutant or in an advisory role for AstraZeneca, Boehringer Ingelheim, Celgene, and Lilly; and received compensation for travel, accommodations and or expenses from AstraZeneca, Boehringer Ingelheim, Celgene, and Lilly. NB has received honoraria from Merck Serono, MSD, AstraZeneca, and BMS; has served as a consutant or in an advisory role for BMS, Merck Serono, and Nanobiotix. DC has received research funding from AbbVie. MS is an employee of Evidera and provided epidemiological support to AZ in the development of this manuscript. HW, PT-A, SW, AK, GM, and NS are employees of AstraZeneca and may hold stock or other ownership in AstraZeneca. The other authors declare that they have no competing interests.