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Fig. 1 | Trials

Fig. 1

From: Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0–2-month-old low birth weight infants in India—the “ProSPoNS” Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial

Fig. 1

Study Design. Study design randomization stratification by sex, birth weight, and study site. ITT, intention-to-treat; PP, per-protocol. One dagger indicates daily during the first week of life, thrice in weeks 2–4 of life, and subsequently weekly in the second month. Two daggers indicate compliance defined as those enrolled infants who have ingested the study drug (for at least 25 days) and were followed up for more than 50% of scheduled visits

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