Study design
This phase 2a study was conducted at three sites in the United Kingdom, with two sites randomizing patients (one site recruited only one patient, who did not subsequently pass screening). The study comprised two parts ((The study was conducted according to the ethical principles of the Declaration of Helsinki and the International Council for Harmonisation Harmonized Tripartite Guideline for Good Clinical Practice. All participants provided written informed consent and the study protocol was approved by the institutional review board of all study sites before commencement of the study.