Authors’ contributions
SW carried out the analyses and produced the first draft. LM performed the patient interviews. VJ and LF led the work described in this paper and made substantial contributions to the conception and design of the trial. SM managed the data. DR, MGW, SP and CG made substantial contributions to the conception and design of the trial. PF provided input from the patient perspective. JY made substantial contributions to the design of the trial and acquisition of the data. All authors read and approved the final manuscript.