Date of first round report: 1 September 2016 Date of second round report: 30 January 2017



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Participant flow


Between 26 Sep 2013 and 26 Aug 2014, 521 patients were randomised at 144 sites in 17 countries (Australia [11 sites], Belgium [11 sites], Canada [11 sites], Germany [2 sites], Ireland [1 site], Italy [9 sites], Japan [8 sites], the Netherlands [6 sites], Portugal [2 sites], Romania [4 sites], the Russian Federation [5 sites], the Republic of South Korea [5 sites], Taiwan [2 sites], Turkey [1 sites], the Ukraine [6 sites], the United Kingdom [4 sites], and the United States [56 sites]).

Table 12: Study A5481023 Analysis populations




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