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The study was conducted over a 48-week period and had two parts: the SLBI phase (24 weeks) and a 24-week extension phase to follow the evolution of the patients; that is, it was a 12-month follow-up study.
All the patients in Group I received SLBI with three wavelengths (635 nm, 536 nm, and 405 nm), 5 mW maximum output power each, in continuous mode, simultaneously, for 20 minutes daily, 7 successive sessions per month, repeated every 7 weeks, for three times.
The SLBI protocol was the same for both Groups I and II, but the placebo patients did not effectively receive the laser radiation through the Weberneedle Lasershower Mouth Applicator.
Clinical assessment and the laboratory findings were performed at study entry (baseline characteristics) (Table 1) and at every 8-week interval of time, before starting each new SLBI set of sessions, for three times, and at 48 weeks (end of study).
The qualified staff who carried out the SLBI knew about the patient being assigned to one group or another, but all the necessary measures were taken so as not to influence the patients' outcome.
At the first evaluation, after 8 weeks from the initiation of this trial, the patients treated with SLBI already displayed a better improvement in all six parameters of the ACR core set data compared with the placebo group, or Group III, respectively.
Patients given SLBI had a greater chance of achieving JIA ACR30/50/70/90 responses at week 24 in comparison with the placebo patients or the Methotrexate group (Table 2).
The differences in the proportions of SLBI patients and placebo patients or Methotrexate group at each JIA ACR response level were statistically significant (P < 0.001).
At the end of the study, the proportion of responders showing the best ACR Pedi responses was higher in patients receiving SLBI, compared with those in Groups II and III.
The efficacy of SLBI proved to trigger a positive evolution of the individual ACR core outcome variables, as presented in Table 2.
At the final evaluation, the SLBI patients continued to display a more significant improvement in comparison with the patients in the other two groups, in all aspects encompassed in the ACR core set data.
All the patients completed the study and were closely monitored for possible side effects of SLBI and/or drugs.
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