Main changes included the following: -The term “parallel-group” was added to the title of the study. -The name of the Sponsor’s responsible physician was updated. -Expected times for site activation, recruitment and approximate total duration of the study were added to the protocol. -The required previous timeframe for patients to repeat the pancolonoscopy at screening was increased from six to twelve months. This would reduce the number of patients requested to undergo an invasive procedure if already done recently. -An exclusion criterion was added to exclude patients receiving treatment with drugs or products containing carnitine or carnitine derivatives during the three months preceding the screening. -The temperature at which the study medication should be maintained was reduced from 30ºC to 25ºC to be more conservative (according to the stability data) with the drug storage conditions. -Some procedural changes and clarifications of the text were made in response to recommendations from Ethics Committees.

Main changes included the following: -Smoking history was added as a screening assessment to better characterize patients. -Due to the fluctuations in symptoms observed in mild patients over short periods of time, it was recommended by the DMB and the Steering Committee that the DAI sub-cores relevant to stool frequency and rectal bleeding be recorded twice during the screening period. -The timeframe of at least four weeks was removed from Inclusion Criterion 3 -Diaphragm and spermicidal agent were removed from Inclusion Criterion 7 as they were not considered to be reliable methods (Pearl Index > 1) and in order to fulfill the criterion of highly effective barrier method. -Patients who had been previously treated with biological agents were excluded from the study without taking any washout period into consideration (Exclusion Criterion 6). -Parasites were added in Exclusion Criterion 7. -Bleeding disorders were clarified in Exclusion Criterion 13: alterations of the coagulation factors or any concurrent other disease possibly causing digestive apparatus bleeding. -The decision to stop study treatment administration due to the use of disallowedmedications was left to the Investigators’ judgment. -The limitation that no more than 150 patients should belong to each study for the interim analysis was changed to 200 patients regardless of their origin. Also, the Independent Statistician was added as being responsible for the interim statistical analysis. In addition, the conditional power threshold was changed from Bt = 0.30 as minimum acceptable value for continuing the trial with no additional evaluations to At = 0.25 threshold under which the trial would be stopped.