Table 1.
Days | Group 1Ni dose | Group 2Ni dose | Group 3Ni dose | Group 4 |
---|---|---|---|---|
1–10 | 1 ng/day | Placebo | Placebo | Placebo |
11–20 | 10 ng/day | 1 ng/day | Placebo | Placebo |
21–30 | 0.1 μg/day | 10 ng/day | 1 ng/day | Placebo |
31–40 | 0.5 μg/day | 0.1 μg/day | 10 ng/day | Placebo |
41–320 | 0.5 μg 3 times a week | 0.1 μg 3 times a week | 10 ng 3 times a week | Placebo 3 times a week |
All eligible patients after one month of Ni-pour diet were randomly assigned to one of the four groups of treatment. Nickel dose was progressively increased in 40 days from 1 ng to 3 definite maintenance doses (10 ng, 0.1 μg and 0.5 μg) administered 3 times a week for a total of 12 months. In order to protect the blinding, patients randomized to lower doses received placebo during the first days of the up-dosing phase.