SAS code for Crypto-HIV study

Scope

This repository contains the SAS code for the Crypto-HIV phase 2 study. The script in the file analysis.sas calls multiple scripts:

• file setup.sas: defining paths
• file macros.sas: defining macros
• file format.sas: defining formats
• file import.sas: importing datasets
• other files in folder code: generating tables, figures, and listings

To generate the full report of all tables, figures, and listings (Crypto-HIV_YYYY-MM-DD.pdf), please submit the SAS code in the file analysis.sas.

In addition, this repository also contains the SAS script for the randomisation (randomisation), a short presentation of the statistical analysis plan (presentation.Rmd), and the SAS and R scripts for reproducing the results from the Crypto-HIV phase 1 study "fed" (reproducibility.sas and reproducibility.Rmd).

Reference

"A 15-week, open-label, randomized, controlled parallel-group trial to evaluate the comparative bioavailability, efficacy and safety of sustained-release flucytosine versus immediate-release flucytosine in adults with cryptococcal meningitis." (https://dndi.org/research-development/portfolio/5fc-cryptococcal-meningitis/)

Acknowledgement

The developer is grateful to Franck Ngangom and Michel Vaillant for comments on the tables, figures, and listings. (Most changes still need to be implemented.)

Disclaimer

This repository is hosted on a personal GitHub account (https://github.com/rauschenberger/Crypto-HIV), but it has a mirror on an institutional GitLab account (https://gitlab.lih.lu/arauschenberger/Crypto-HIV).

Copyright © 2023 Armin Rauschenberger ; Luxembourg Institute of Health (LIH), Department of Medical Informatics (DMI), Bioinformatics and Artificial Intelligence (BioAI) and Competence Centre for Methodology and Statistics (CCMS). This SAS code is distributed under the BSD-3-Clause license.

Warning

This SAS code is still under development and has not yet been reviewed. It has not been validated and should not be used to support regulatory submissions.