Funding for this research was provided by:
Received: 13 December 2019
Accepted: 3 June 2020
First Online: 15 June 2020
Ethics approval and consent to participate
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This protocol was approved by the relevant institutional review boards and all subjects or authorized representatives signed informed consent prior to the conduct of study procedures.It is not our policy to disclose information about enrollment at particular centers or to identify centers where a particular patient was enrolled, as this potentially could unmask patient identity. Providing detailed information about ethics committees could reveal the enrollment center and contribute to patient unmasking, particularly in a report such as this one where individual data on only three patients (as opposed to aggregate data) is reported. However, we can confirm that the overall A16 study (NCT # 02516046) was reviewed and approved by a central IRB (Advarra, formerly Schulman Associates, IRB, 6940 Columbia Gateway Dr., Suite 110, Columbia, MD 21046).
: The consent form signed by each patient or representative included the statement: study data that does not directly identify you may be published in medical journals or shared with others as part of scientific discussions. A copy of our template consent form (required text for all sites) is available on request.
: MJP, AKA, MDD, MN, IK, ML, PA, MF, ASF, and MAM are full-time employees of Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, and are minor stockholders of Eli Lilly and Company. ADJ and AS were employees of Avid at the time this work was performed but are now at Medpace Holdings and University of Pennsylvania, respectively. TGB, TJM, CDK, GES, LIS, AJI, SER, AW, LH, and NC contributed to this work as part of a research contract with Avid.