Table 1 Study timetable and activities
Phase | Duration | Activities |
|---|---|---|
Phase 1 | 6 months | 1- Preparation of the study team |
2- Preparation of the study drugs | ||
3- Design of the study forms including patient database and inform consent | ||
4- Trial approval by the required organization or body | ||
5- Task distribution and training | ||
Phase 1 | 12 months | 1- Patient selection |
2- Randomization | ||
3- Administration of the trial treatment | ||
4- Patient evaluation (pre−/post-trial) | ||
5- Assessment of the target outcomes | ||
6- Evaluation of complications or adverse reaction, if any | ||
7- Analysis |