Objective In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D 3 in patients with RRMS. Methods Eligible patients with RRMS treated with SC interferon-β-1a (IFN-β-1a) 44 μg 3 times weekly and serum 25(OH)D levels <150 nmol/L were included. From February 15, 2011, to May 11, 2015, 229 patients were included and randomized 1:1 to receive SC IFN-β-1a plus placebo (n = 116) or SC IFN-β-1a plus oral high-dose vitamin D 3 14,007 IU/d (n = 113). The revised primary outcome was the proportion of patients with no evidence of disease activity (NEDA-3) at week 48. Results At 48 weeks, 36.3% of patients who received high-dose vitamin D 3 had NEDA-3, without a statistically significant difference in NEDA-3 status between groups (placebo 35.3%; odds ratio 0.93; 95% confidence interval [CI] 0.53-1.63; p = 0.80). Compared with placebo, the high-dose vitamin D 3 group had better MRI outcomes for combined unique active lesions (incidence rate ratio 0.68; 95% CI 0.52-0.89; p = 0.0045) and change from baseline in total volume of T2 lesions (difference in mean ranks: −0.074; p = 0.035). Conclusions SOLAR did not establish a benefit for high-dose vitamin D 3 as add-on to IFN-β-1a, based on the primary outcome of NEDA-3, but findings from exploratory outcomes suggest protective effects on development of new MRI lesions in patients with RRMS. Clinicaltrials.gov identifier NCT01285401. Classification of evidence This study provides Class II evidence that for patients with RRMS treated with SC IFN-β-1a, 48 weeks of cholecalciferol supplementation did not promote NEDA-3 status.

Data regarding vehicle accidents per hour of the day were supplied by the Italian National Institute of Statistics (ISTAT) and by the Italian Automobile Club (ACI).Data regarding traffic density in the corresponding time span were supplied by the Italian Highways Society. 5 Analysis of Sleep Ascribed AccidentsThe criteria used by police officers to ascribe a given accident to sleepiness are the following:• Suspicion of sleepiness as the major cause, stated by the policeman called on the accident scene. It is based on the pres-Study objective: To evaluate the contributing role of sleepiness in Italian highway vehicle accidents during the time span 1993-1997. Design: We analyzed separately the hourly distribution of accidents ascribed by police officers univocally to sleepiness and the rest. Patients: N/A Interventions: N/A Measurements: Using a polynomial regression, we evaluated the relation between accidents (whether sleep-ascribed or not) and sleepiness as derived from a 24-hour sleep propensity curve. The relation between sleep-influenced and non-sleep influenced accidents was analysed using a linear regression Results: The rate of non-sleep ascribed accidents is closely related with sleep propensity and bears a strong similarity with the pattern of sleepascribed accidents. A close relationship between the curves of non-sleep ascribed accidents and sleep-ascribed accidents is confirmed.The regression coefficient, which can be seen as the ratio between the quota of accidents that can be considered as sleep affected and those actually ascribed to sleepiness, results in a value of 5.83. Considering that the rate of sleep ascribed accidents is 3.2%, we can calculate the quota of sleep influenced accidents out of those not officially ascribed to sleepiness as 18.7% reaching an estimate of accidents related in some way to sleepiness equal to 21.9%. Conclusions: Our indirect estimate of sleep influenced accidents approaches data reported by other European countries and highlights the importance of sleepiness as a direct and/or contributing factor in vehicle accident rates.

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