Trial design and oversight
-11
We conducted a randomised, double-blind, placebo-controlled trial at three sites in the United Kingdom. The study was prospectively registered with EudraCT (Registration Number: 2015-005402-11) and overseen by the sponsor, King’s Health Partners. The study was conducted in adherence with the Good Clinical Practice Guidelines and the principles of the Declaration of Helsinki. The protocol was approved by London—Westminster Research Ethics Committee (REC Reference: 16/LO/1144).