Table 1.
Demographic characteristics of all subjects exposed to RV16 (ITT population n = 146).
| Parameter | Statistic | 0 g/Day | 0.3 g/Day | 1.5 g/Day | p-Value * |
|---|---|---|---|---|---|
| N | 46 | 49 | 51 | ||
| Age (y) | Mean ± SD | 38.2 ± 15.8 | 35.4 ± 14.4 | 34.5 ± 14.9 | 0.46 |
| Male (%) | N (%) | 10 (22) | 10 (20) | 9 (18) | 0.88 |
| BMI (kg/m2) | Mean ± SD | 23.2 ± 2.6 | 23.5 ± 2.9 | 23.8 ± 2.7 | 0.58 |
| Alcohol consumption (glasses/week) | Median (range) | 2 (0–10) | 1 (0–12) | 0 (0–10) | 0.68 |
| Vegetarian diet (N) | Median (range) | 0 (0–1) | 0 (0–1) | 0 (0–1) | 0.98 |
* Baseline differences over treatment groups were tested with ANOVA (age and BMI) or Kruskal–Wallis (gender, alcohol use, vegetarian diet). Characteristics of enrolled population and nested subset as well as details on inclusion, exclusion (e.g., smoking, allergies and underlying lung diseases) and restriction criteria are provided in the online data in the Supplementary Materials.