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. Author manuscript; available in PMC: 2016 Dec 17.
Published in final edited form as: Lancet. 2016 Nov 16;388(10062):2873–2884. doi: 10.1016/S0140-6736(16)31275-2

Figure 2. Least squares estimates of mean change from baseline in ADAS-Cog (A), ADCS-ADL (B), and lateral ventricular volume (C).

Figure 2

We did the estimates with either the primary analysis model with Alzheimer’s disease comedication status as an additive term in the model (A1, B1, C1), or a prespecified repeat of the primary analysis with Alzheimer’s disease comedication status as an interaction term in the model showing effect of leuco-methylthioninium bis(hydromethanesulfonate) treatment as either monotherapy or as add-on to existing Alzheimer’s disease treatments (A2, B2, C2). In both these analyses, the control group is as randomised. In a further non-prespecified analysis, we compared patients randomised to the control arm taking 4 mg leuco-methylthioninium bis(hydromethanesulfonate) treatment as either monotherapy or as add-on to existing Alzheimer’s disease treatments (A3, B3, C3). Numbers of participants analysed in each of the study group are shown in tables 2 and 3, and in the appendix, and numbers completing treatment with 4 mg, 75 mg, or 125 mg twice daily are shown in figure 1, according to Alzheimer’s disease comedication status. Corresponding results for ADCS-CGIC and MMSE are shown in the appendix. ADAS-Cog=Alzheimer’s Disease Assessment Scale–Cognitive Subscale. ADCS-ADL=Alzheimer’s Disease Co-operative Study–Activities of Daily Living. ADCS-CGIC=Alzheimer’s Disease Cooperative Study–Clinical Global Impression of Change scale.