Gottlieb, Alice
Gratacos, Jordi
Dikranian, Ara
van Tubergen, Astrid
Fallon, Lara
Emir, Birol
Aikman, Laraine
Smith, Timothy
Chen, Linda
Funding for this research was provided by:
Pfizer Inc.
Article History
Received: 10 September 2018
Accepted: 2 November 2018
First Online: 13 November 2018
Compliance with ethical standards
:
: A Gottlieb is a consultant/advisory board member and is a member of the speakers’ bureaus for AbbVie, Allergan, Beiersdorf Inc., Bristol-Myers Squibb, Celgene Corp, Dermira, Incyte, Janssen, Lilly, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB, Valeant, and XBiotech, and has received research/educational grants from Incyte, Janssen, Lilly, Novartis and UCB. J Gratacos has received consulting fees or other remuneration from AbbVie, Celgene, Janssen-Cilag, MSD, Novartis, Pfizer Inc, and UCB. A Dikranian has received consulting fees or other remuneration from, and has held non-remunerative positions of influence with, AbbVie and Pfizer Inc, is a member of an advisory board for Novartis and Pfizer Inc, and is a member of the speakers’ bureaus for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Mallinckrodt, Novartis, and Pfizer Inc. A van Tubergen has received grants, research, or clinical trial support from AbbVie, Celgene, Janssen-Cilag, MSD, Novartis, Pfizer Inc, and UCB, is a member of the speakers’ bureaus for Janssen-Cilag, MSD, and Pfizer Inc, and is a consultant or member of an advisory board for Janssen-Cilag, Novartis, and Pfizer Inc. L Fallon, B Emir, L Aikman, and T Smith are shareholders and employees of Pfizer Inc. L Aikman is a shareholder of Pfizer Inc and former employee of Pfizer UK. L Chen is a shareholder and former employee of Pfizer Inc.
: This article does not contain any studies with animals performed by any of the authors.
: This study was reviewed and approved by the Pearl Institutional Review Board (IRB). Informed consent was obtained from all individual participants included in the study. The US IRB study number is 16-KAN-127 and the EU study number is 16-KAN-123.
: Upon request, and subject to certain criteria, conditions and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.