Methodological considerations
RECRUITMENT, BLIND
This study has several strengths: a sample size calculation was performed prior to recruitment; the trial reached the intended number of participants; randomization was conducted with adequate allocation concealment; blinding of researchers was obtained during analysis and while writing the conclusion; all outcomes are reported; analysis was based on intention-to-treat analysis; and MA&R was delivered with good and optimal fidelity and with relatively low attrition rates. The study also has limitations: it was not possible to blind participants and staff to intervention allocation, and this increased the risk of expectation and collateral intervention bias [