Section and Topic

Checklist item

Location where item is reported

Project overview

Title

Protocol summary

Investigators/collaborators

Introduction

Rationale: describe the rationale for the LOH or FH study in the context of existing knowledge

Objective & Hypotheses: Provide an explicit of the objectives & hypotheses on the study on LOH or FH

Justification for the study

Method/Procedure

Design

How the study design will meet the objectives and address hypotheses

Study time line

Protocol review request

Study Population

Case definition for LOH and FH

Eligibility criteria: Should include inclusion and exclusion criteria for both participants and control for the study

Sample size, sampling and statistical power

Enrolment for the study

Interventions or variables

Study instruments including questionnaires, laboratory instruments and analytic test

Intervention or treatment to be given to LOH of FH, at what interval and duration?

Outcomes: Should include major adverse cardiovascular events as part of the primary outcome measures

Data handling and Analysis

Data collection

Data entry, editing and management including storage

Quality control and assurance

Bias in data collection, measurement and analysis

Limitation of study

Adverse Events or Unexpected Findings

Identify, managing and reporting of adverse events to interventions or placebo used in the study

Emergency care available

Notification, Reporting & Dissemination of Results

Notify participants of their individual results and study findings

Disseminate results on LOH and FH to the public

References

Appendix Material

Data collection form and other relevant documents

Tables and figures