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Background and ObjectiveOnce-daily oral fingolimod is approved in the EU as escalation treatment for adult patients with highly active relapsing multiple sclerosis (MS). The efficacy and safety profiles of fingolimod have been well established in a large clinical development programme and several papers reflecting the experience with fingolimod in real-world settings have been published to date. The GOLEMS study was designed to evaluate the efficacy, safety and tolerability of fingolimod and the impact of fingolimod treatment on disability progression and work capability in patients with MS in routine clinical practice in the Czech Republic.MethodsGOLEMS was a national, multicentre, non-interventional, single-arm study conducted to analyse the outcomes of a minimum of 12 months of fingolimod therapy on primary and secondary endpoints. The primary endpoint was to assess the proportion of relapse-free patients and severity of MS relapses in patients treated with fingolimod for 12 months. Secondary endpoints included assessment of changes in disability progression evaluated by the Expanded Disability Status Scale (EDSS) score and work capability assessment measured through voluntary completion of the WPAI-GH questionnaire. The predictive factors for relapse-free status during fingolimod treatment were also analysed.ResultsOf the 240 enrolled patients, 219 completed the 12-month treatment period at the time of final analysis. In the efficacy set (N = 237), the proportion of relapse-free patients increased from 47 patients (19.6 %; 95 % confidence interval [CI] 14.8–25.2) in the year before fingolimod initiation to 152 patients (64.1 %; 95 % CI 58.0–70.2) after 1 year of fingolimod treatment. Of the 85 patients who experienced at least one relapse after 1 year of fingolimod treatment, 53 (62.4 %; 95 % CI 51.7–71.9) reported only one relapse, while 25 (29.4 %; 95 % CI 20.8–39.8) and seven (8.2 %; 95 % CI 4.0–16.0) patients had ≥2 relapses, respectively. No significant changes were observed in EDSS scores over the 12-month treatment period compared with baseline. The absolute number of relapses during 2 years before initiation of fingolimod treatment and baseline EDSS scores were identified as significant independent predictors for ‘being relapse-free’ during the 12-month fingolimod treatment period. No trend was established in work capability or number of missed days at work due to the large proportion of missing data. Of 240 enrolled patients, 27 (11.3 %) patients discontinued the study at or before the 12-month visit, 16 (6.7 %) discontinued because of adverse events related to study drug. Only six (2.5 %) patients reported serious adverse events related to the study drug.ConclusionThe results confirm the favourable safety and efficacy profile of fingolimod under real-world conditions, consistent with phase III trials.

Potential and current density distributions were modelled and measured for an electrochemical cell with a bipolar electrode. The dimension of the bipolar electrode in the direction of current flow was extended, to enable experimental determination of the electrode potential and the local current densities at various positions inside the electrolyte and in the electrode body. The experimental results showed that the most active regions of the bipolar electrode are located at the ends of the bipolar electrode facing the terminal electrodes. The equations corresponding to the mathematical model of the experimental cell were solved using the finite volume method and gave very good qualitative agreement with the experimental data. However, some discrepancies between model predictions and experimental data were evident in the active parts of the bipolar electrode and in the variation of the terminal voltage with the total current. This was explained in terms of the active electrolyte cross-section and the electrode surface area being diminished due to the presence of gas bubbles in the system.Keywords Bipolar electrode Á Mathematical modelling Á Parasitic current Á Local potential and current density distribution Nomenclature A F Cross-sectional area of the free electrolyte space beside the bipolar electrode (m 2 ) d G Inter-electrode distance (m) d E Bipolar electrode thickness (m) E Electrode potential (V) f E Current utilisation in a bipolar cell (-) I Current (A) I E Current flowing through bipolar electrode (A) I P Parasitic current (A) I T Total current (A) j Current density (A m -2 ) n Vector normal to the boundary (m) N Number of electrolytic cells (-) r Radius (m) RResistivity (X) R F Electrolyte resistivity in the fictitious electrolyser (X) R G Average resistivity of the inter-electrode gap (X) R S Short-circuit resistivity (X) S Electrode surface (m 2 ) U Voltage (V) U r Open-circuit cell voltage (V)xPosition along the cell (m)Greek letters u Galvani potential (V) r Conductivity (S m -1 ) j F Electrolyte conductivity (S m -1 ) g Overpotential (V)

This work presents a novel approach combining reverse electrodialysis (RED) and alkaline polymer electrolyte water electrolysis (APWEL) for renewable hydrogen production. APWEL is fuelled by salinity gradient power (SGP) extracted from sulfate (SO4 2-)-rich industrial wastewater. The performance of a pilot-scale RED unit (200 cells, active area: 31.5×63.5 cm 2), using salt solutions mimicking sulfate-rich waste streams (0.01-0.3 M Na2SO4), was evaluated. An open circuit voltage (OCV) of 12.3 V, a maximum power density of 0.22 W/m 2 MP (MP: membrane pair) and internal area resistance of 43.2 Ωcm 2 /cell were recorded by using 0.01 M/0.3 M Na2SO4 solutions at 35 o C. The APWEL stack (6 cells, active area: 5×5 cm 2), equipped with Ni foam electrodes and heterogeneous anion-selective membranes, was tested with varying concentrations of liquid electrolyte (0.85-2.5 M KOH) and varying temperatures (28-48 o C). The APWEL stack attained a maximum current density of 110 mA/m 2 at 1.85 V/cell (i.e. 11 V per stack), 2.5 M KOH and 48 o C. Under these conditions, the integrated system exhibited a maximum hydrogen production rate of 50 cm 3 /h•cm 2. This study opens up a new perspective on renewable hydrogen production fuelled by nonintermittent SGP from SO4 2-rich industrial effluents.

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