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Notas:
This summarises the design and dosing schedule.
Patients meeting eligibility criteria will be randomised in a 1: 1: 1 manner to one of the three treatment groups. Following titration to maximum tolerated/allowed doses of study medication at intervals of 2 weeks, they enter an 18 month maintenance period during which time assessments are made every three months.
It is importmat for Investigators and study personnel to emphasise to patients that they must inform them if stduy medication is stopped for any reason and for any length if time. Will say more about this later in the presentation
Two phase titration; done in a blinded manner with double dummy medication presentation which means that this will be seamless to the Investigators. Some more detail later in this presentation; presentation on how ClinPhone system will facilitate titration this afternoon.
