Alternatively, an explanation of why a DMC is not Interventions for each group with sufficient detail to allow replication, including how and when they will be administered Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease) Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions needed Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how Description of any interim analyses and stopping guidelines, including who will have access to these the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions interim results and make the final decision to terminate the trial Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse Authorship eligibility guidelines and any intended use of professional writers If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's events and other unintended effects of trial interventions or trial conduct Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code ___10_______ _____11______ _______30______ ______15_____ _____10_______ ______14_____ ____33______ _____11_____ ________25_____ _____11_____ ____33______ _______30______ ______14_____ ____NA______ _____33______ 11c 23 Methods: Data collection, management, and analysis Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence allocated intervention during the trial Auditing Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent Appendices from investigators and the sponsor (eg, drug tablet return, laboratory tests) Informed consent 32 Model consent form and other related documentation given to participants and authorised surrogates _____14______ ______33_______ _____39_____ 11d 18a Ethics and dissemination Data collection materials Relevant concomitant care and interventions that are permitted or prohibited during the trial Plans for assessment and collection of outcome, baseline, and other trial data, including any related _____15_____ ______16____ Outcomes methods Research ethics Biological 12 24 33 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of Plans for seeking research ethics committee/institutional review board (REC/IRB) approval Plans for collection _______38_____ approval specimens pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known.