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Table 4 Analysis of Efficacy adjusting for the three most frequent Nervous System Disorder AEs – summary of ANOVA

From: Assessment of blinding to treatment allocation in studies of a cannabis-based medicine (Sativex®) in people with multiple sclerosis: a new approach

 

P-values

Source

Model 1

Model 2

Model 3

Model 4

Baseline severity (BS)

   

<0.0001

Study (ST)

   

0.15

Adverse event (AE)

   

0.49

Treatment group (TG)

   

0.033

AE*ST

0.008

0.011

0.010

0.017

TG*AE

0.15

0.13

0.13

 

TG*ST

0.80

0.79

  

TG*AE*ST

0.69

   

Estimated effect of AE occurrence on spasticity NRS (95% CI)

Previous users:

−1.08 (−1.35 to −0.82)

No previous use:

−1.20 (−1.38 to −1.01)

Estimated difference:

−0.11 (−0.44 to 0.21)