Table 5 Comparison of primary efficacy variables between each THP and the NRT.

From: An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy

Parameter

Geometric LS mean

Geometric LS mean 90% CI

Ratioa

Ratio 90% CI

P value

Non-inferiority test b

Superiority test c

PLQ (AUC3–240 min)

THP1.0(RT)

94.0

(38.50, 229.30)

2.61

(1.227, –)

0.0235

Accepted

 

NRT

36.0

(14.60, 88.69)

THP1.1(RT)

191.5

(76.49, 479.17)

5.32

(2.451, –)

0.0012

Accepted

 

NRT

36.0

(14.60, 88.69)

OUIA (actual values)

THP1.0(RT)

2.48

(1.98, 3.10)

1.61

(1.395, –)

 < 0.0001

Accepted

 

NRT

1.54

(1.23, 1.93)

THP1.1(RT)

2.98

(2.37, 3.74)

1.94

(1.670, –)

 < 0.0001

Accepted

 

NRT

1.54

(1.23, 1.93)

UTS (AUC3-240 min)

THP1.0(RT)

1570.3

(1381.55, 1784.79)

1.01

(–, 1.084)

0.5816

 

Rejected

NRT

1552.9

(1365.51, 1765.96)

THP1.1(RT)

1492.8

(1311.34, 1699.44)

0.96

(–, 1.033)

0.2397

 

Rejected

NRT

1552.9

(1365.51, 1765.96)

Mean UFP d

THP1.0(RT)

2.54

(2.04, 3.17)

1.35

(1.152, –)

0.0087

 

Accepted

NRT

1.88

(1.51, 2.36)

THP1.1(RT)

3.09

(2.46, 3.87)

1.64

(1.392, –)

0.0001

 

Accepted

NRT

1.88

(1.51, 2.36)

  1. Parameters were log transformed and 1 was added to avoid a logarithm of 0. The transformed parameters were analysed by an ANOVA model, including treatment, sequence and period as fixed effects, and subject-within-sequence as a random effect.
  2. CI confidence interval, LS least squares, THP tobacco heating product, NRT nicotine replacement therapy.
  3. aCalculated by transforming the difference between the natural log LS means back to the original scale.
  4. bPLQ and OIUA were confirmed as non-inferior if the lower bound of the one-sided 90% Cl of the ratio was more than 0.80.
  5. cUTS was confirmed as superior if the upper bound of the one-sided 90% Cl of the ratio was less than 1.0. UFP was confirmed as superior if the lower bound of the one-sided 90% Cl of the ratio was more than 1.0.
  6. dMean of the scores recorded at 15 and 120 min.
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