Study Oversight
The trial is titled: Phase III randomised study of FO licA cid supplementation in the management of M enopausal symptoms in cancer survivors and healthy postmenopausal women (FOAM Trial). It was co-sponsored by Sandwell and West Birmingham Hospitals NHS Trust and University of Birmingham, and was conducted under the auspices of the Cancer Research UK Clinical Trial Unit (CRCTU Ref No.: MX3009). Guys’ and St Thomas’ Hospital Pharmacy Manufacturing Unit was responsible for purchasing the trial drug from Actavis (Devon, UK, rebranded as Accord Healthcare in January 2017), and for manufacturing the placebo tablets. Study oversight and monitoring were provided by a trial steering committee and by an independent data and safety monitoring committee. The trial protocol and ethical approval are submitted as Supplementary Document 1 and 2, respectively.