Funding for this research was provided by:
Received: 18 March 2019
Accepted: 25 September 2019
First Online: 26 October 2019
Ethics approval and consent to participate
: This observational study included no administration of any therapeutic or prophylactic agent. There were no anticipated physical risks or direct benefits to patients participating in the study, although patients may become uncomfortable or emotional discussing their experiences with carcinoid syndrome symptoms. As such, participation was completely voluntary and participants could withdraw at any time and still receive (as applicable) the full exit study incentive. Participation in the exit interview was not a requirement for TELESTAR clinical trial participation (e.g., should a patient decide not to participate in an exit interview, they could still continue in any remaining clinical trial activities [e.g., open-label treatment period]). An incentive for participation in the exit interview substudy was provided, if approved by each participating clinical site’s local ethics review board, to compensate patients for their time. The amount and payment methods was reviewed and approved by each ethics committee to ensure that payments (if allowed) were commensurate with the time needed to participate in the interview and were not coercive.
: Not applicable.
: S. Hudgens and J. Gable are employed by Clinical Outcomes Solutions, the organization contracted by Lexicon to analyze the data and develop this manuscript. These authors have no additional financial relationships or otherwise to declare. M. Kulke has received consulting fees from Lexicon, Novartis, and Ipsen outside the submitted work. E. Bergsland is an uncompensated adviser for Lexicon Pharmaceuticals, Inc., and Ipsen. L. Anthony has received grants from Lexicon Pharmaceuticals Inc. M. Caplin has received compensation from Lexicon Pharmaceuticals Inc for participation on an advisory board. K. Öberg has received honoraria and speakers’ bureau fees from Novartis and Ipsen. M. Pavel has received consulting fees from Lexicon Pharmaceuticals Inc, Novartis, and Ipsen. P. Banks, Q.M. Yang, and P. Lapuerta are all currently employees of Lexicon Pharmaceuticals Inc and own stock. The authors have declared that they have no other competing interests regarding the content of this article.