Lysis based on a logistic regression model will be carried out, taking into account relevant factors, such as gender, time from MS diagnosis, 3-dihydrobenzoimidazol-2-one Piperazin-1-yl(pyridin-2-yl)methanone dihydrochloride 2-Bromo-1 concomitant treatments and EDSS at baseline. A secondary analysis of treatment effect will also be performed by comparing the distribution of each category of the combined end point in the two treatment groups. The treatment effect on each single functional parameter of the combined end point will also be assessed using the Hochberg correction for multiple testing [54]. The MRI end point will be evaluatedIf not explicitly mentioned in the inclusion or exclusion criteria, the concomitant therapies for chronic pathologies not correlated with MS will be continued throughout the study period. All drugs given to participants during the study will be recorded in the e-CRF. All pharmacological or rehabilitative treatments (motor reeducation and balance, walking and cognitive training), carried out during the study and in the six months PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/23410069 previous randomization will be recorded in the e-CRF. Changes considered in the regimen of treatments with potentially relevant effects on the tested functions (for example, changes in type and intensity of physiotherapy, new assumption of antispastic drugs) will be recorded and taken into account in the data analyses. The implantation of a baclofen pump will lead to the classification of the patient as “worsened.”Monitoring of the studyThe monitoring procedures will be entrusted to a CRO. During the study, monitoring personnel will visit the participating centers on a regular basis to verify completeness of the data, accuracy of completion of the data collection forms, adherence to the study protocol and to good clinical practice (GCP), and state of the enrollment or any other problems. The treating neurologist will provide the monitors with full access to clinical data to confirm the consistency of the information recorded on the e-CRF. All information relative to Dimethyl 4-iodopyridine-2,6-dicarboxylate patient identity must be kept confidential according to Italian law (D. Lvo 96/Zamboni et al. Trials 2012, 13:183 PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/8627573 http://www.trialsjournal.com/content/13/1/Page 10 ofTable 6 Safety results that provide a posterior probability of 90 or more of observing a percentage of serious adverse events in the overall sample higher than an acceptable maximum (4 )Number of serious adverse events 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Number of cumulative patients in study 13 to 27 28 to 44 45 to 61 62 to 79 80 to 98 99 to 117 118 to 137 138 to 157 158 to 177 178 to 198 199 to 218 219 to 239 240 to 260 261 to 281 282 to 302 303 to 323 324 to 345 346 to 366 367 to 388 389 to 410 411 to 431 432 to 453 454 to 475 1-(4-Bromo-2-pyridyl)piperazine 476 to 497 498 to 519 520 to 541 542 to 563 564 to 585 586 to 608 609 to 630 631 to 652 653 to 674 675 toin close contact with the DCC and the CRO. The IDMC will receive a report to evaluate the progress and safety of the study every 3 months in the first year and every 4 months from the second year on, and it will inform the SC of any recommendations for an early interruption of the study. The reporting form will be defined in collaboration with the DCC and the CRO, it will be approved by SC and it will be produced by the CRO in a blinded form. Only the IDCM and the party responsible for the quality of the data may ask for an unblinded version of the report. The IDMC will evaluate safety, also taking into account early stopping rules. The IDMC will also consider whet.