 Masking: Sequentially numbered boxes containing identical LOLA or placebo ampoules, according to the allocation sequence will ensure allocation concealment. The numbering of the boxes will be done by research coordinator, and concealed from the treating consultants. All study personnel will be blinded to the treatment assignment placebo or LOLA for the duration of the study. Placebo and LOLA will be similar in appearance and in the mode of administration. The code of the allocation sequence will remain with the research coordinator. It will be revealed only after the recruitment, data collection and analysis of results has been carried out. The coordinator will not have any access to the patients involved in the study. 