Data availability
The individual participant data from this study cannot be made publicly available due to the sponsor, Carrick Therapeutics, contractual obligations. Data may be requested after the product and indication has been approved by major health authorities and/or 24 months after completion of all the clinical study reports for the reported arms of the NCT03363893 trial (anticipated to be completed by the end of 2023). Researchers should submit a proposal to the corresponding author (matthew.krebs@manchester.ac.uk) outlining the reasons for requiring the data. Applications should specifically outline the data the parties are interested in receiving and how the data will be used; the use of the data must also comply with the country- or region-specific regulations and will be supplied as de-identified data so individual participants cannot be identified. The corresponding author and sponsor will endeavor to respond to requests within 6 weeks of receipt. A signed data access agreement with the sponsor is required before accessing the shared data and access will be limited to a defined period (to be agreed with the requestor). Study protocols (core protocol plus Module 1B-1 and Module 2 protocols) are included in the Supplementary Information file. The remaining data are available within the article and its Supplementary Information.