This component includes the original study protocol (Arnold et al. 2013) and a short update that pre-specifies some small changes and additional details in the trial's statistical analysis plan. All decisions were made fully blinded to the trial's randomization assignment and before opening the trial's primary outcome data. **Replication and blinding** The primary analysis -- including data management -- was conducted fully masked in duplicate by two independent team members, Drs. Benjamin Arnold and Jade Benjamin-Chung. We unblinded the trial's randomization assignment only after independent primary analyses achieve perfect replication.
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