Document is current

Article History

Received: 21 June 2023

Accepted: 18 August 2023

First Online: 26 September 2023

Declarations

:

: Caroline R. Perry, Nicole E. Scangarella-Oman, Helen Millns, William Flight, Sally Gatsi, Charles Jakielaszek, and Salim Janmohamed are employees of, and shareholders in, GSK. David A. Lewis is employed by Western Sydney Local Health District and has no disclosures to declare.

: These studies are conducted in accordance with the protocols and consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, International Council on Harmonization Good Clinical Practice Guidelines, and applicable laws and regulations. Protocol and amendments, informed consent form/adolescent assent form/eConsent (if applicable), investigator’s brochure, and other relevant documents (e.g., advertisements) were submitted to an institutional review board/independent ethics committee (IRB/IEC) by the investigator and reviewed and approved by the IRB/IEC before the study was initiated. The master IRB was Advarra Institutional Review Board (Columbia, MD, USA), while study sites outside the USA used their appropriate local IRB/IEC. Adolescent patients will only be enrolled at study sites where investigators have experience in this population and if allowed per the study site’s institutional ethics committees and local country/national regulatory guidelines; enrollment will be contingent upon such approvals.