Group 1 and group 2 defines arbitrary groups. Clinics may have a mixture of group 1 and group 2 patients; such clinics will have some patients who have signed consents and who will be randomized "at home" (group 2 patient) and others who are randomized and receive study drug "in centre". Irrespective of where patients are at the time of randomization they will be allocated the next available study drug supply at the time of randomization.