The changes included: 1.Addition of text to clarify that informed consent was to be obtained and signed by the participant prior to any study-related procedures at screening and that the participant must have met all the inclusion and none of the exclusion criteria on day -1. 2.Update of the alcohol exclusionary alcohol consumption limit for males and females in the exclusion criteria from a higher allowed weekly limit to a lower allowed daily limit. 3.Addition of exclusion criterion to exclude participants with abnormal renal function, indicated by creatinine above the upper limit of normal or chronic kidney disease (CKD) epidemiology collaboration based on the estimated glomerular filtration rate of < 90 milliliter/minute (mL/min) on day -1. 4. Addition of pregnancy to the reasons why a participant must have discontinued from study treatment. 5. Update to text to state that the premature termination of the study for reasonable cause was not optional. Addition of reasons that was to result in premature discontinuation of the study and of text to state that the whole study may have been terminated or suspended upon the request of regulatory authorities. In addition, text was added to state that regulatory authorities and the independent ethics committee (IEC) was to be informed about the discontinuation of the study.