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5��C or above (or feels hot to touch); temperature less than 35.4��C (or feels cold to touch); lethargic or unconscious or less than normal movements. Fieldworkers referred and accompanied sick infants to the study hospital for treatment. At the hospital, the infants were examined by a physician, blood cultures were obtained, and treatment was carried out as per the protocol of the hospital. Information on compliance and morbidities was recorded. An enrolment card was provided which parents were asked to carry whenever they sought treatment for the infant in between study visits. Efforts were made to contact local practitioners visited independently by parents of infants and to collect the details of treatments prescribed. Study staff were trained in the IMNCI algorithm and given Oxygenase practice on eliciting signs of neonatal sepsis. Study procedures were standardised and regular exercises were conducted so as to reduce interobserver and intraobserver variability. Quality assurance measures included supervisory checks in the fieldwork, data collection and data cleaning. All case record forms were cross-checked by supervisors and medical officers before being sent for double data entry (in EPI Info V.6.0) with built-in range and consistency checks. (Details on quality assurance mechanism for the study implementation is given as web appendix). The primary outcome was risk of PSBI as per the IMNCI algorithm, as diagnosed by fieldworkers or physicians. Secondary outcomes were estimation of the effect of VSL#3 on overall morbidity pattern in 0�C2-month-old LBW infants; stool colonisation patterns in 10% of subjects; and assessment of side effects due to the probiotic VSL#3, if any. On the recommendation of the DSMC, data on diagnosis of sepsis by a physician was also recorded as an amendment to the protocol. Gut colonisation substudy Data on gut colonisation was important to substantiate the clinical findings. Stool samples from 202 (101 each in the intervention and placebo arms) enrolled infants were collected on day ��1��, day ��21�� and day ��60�� to correspond to the end of follow-up. The samples were collected in sterile specimen jars (plastic containers) and transported to the lab at 4��C, and stored at ?20��C. Processing was completed within 10?days to evaluate their bacterial microflora composition and enzymatic activities. Sequencing and real-time PCR were conducted on DNA samples extracted from stool specimens. Statistical analysis Bang et al2 reported a 17% incidence of neonatal sepsis in the community. Assuming a 10% loss to follow-up, 1340 infants were needed (670 in each group) to observe a 30% reduction in incidence of sepsis at 5% significance with 80% power. Analyses were performed by intention to treat. Software ��R��17 (V.3.0.0) was used for calculation of PSBI risk, incidence rates, CIs and incidence rate ratios.