Flow diagram of clusters and participants of PROBIT recruitment follow-up phases at 12 mo, 6.5 y, 11.5 y, and 16 y.

<p>^a: During the 11.5-y follow-up, 6 deaths were reported in the intervention arm. Data-checking during the 16-y follow-up found one of these children had been incorrectly reported as deceased and data were amended. ^b: Of the 13,557 seen at the 16-y follow-up, 12,072 were seen at both 11.5-y and 16-y follow-ups, 274 were not seen at either 6.5-y or 11.5-y follow-ups, 449 were seen at 6.5 y but not seen at 11.5 y, and 762 were seen at 11.5 y but not seen at 6.5 y. Of the 3,489 children randomized but not followed up at 16 y, 267 attended the excluded site, 116 died after randomization, 2,674 were lost to follow-up, and 432 were unable or unwilling to come for their clinic visit.