Author contributions
TEN, HT
YKu, TT, EO, YS, SI, HT, TEN, and TY comprised the steering committee, which coordinated trial implementation at all sites, including coordination of the study protocol and resolution of doubts in its interpretation. YKu, TT, TM, MN, JW, HO, AM, MK, HH, YKa, NS, HK, AT, TK, EO, YS, SI, HT, TEN, and TY collected data. All authors interpreted the data, and SM analysed the data. YKu, TY, and SM have accessed and verified the data. TY was responsible for the decision to submit the manuscript.