FUNDING/SUPPORT AND ROLE OF THE SPONSOR: The initial phase of this study (up-to 3 years follow-up) was funded by a grant from the Henry Smith Charity (Address: 6th Floor, 65 Leadenhall Street,London EC3A2AD). Registered Charity Number – 230102. D. Karmakar was funded by IUGA Clinical Fellowship Grant 2014.Peer reviewedPostprin