Table 3 Protocol versions
Version | Date and changes |
|---|---|
1.0 | May 21, 2018—Original protocol |
1.1 | June 16, 2018—Proposed dose azithromycin as 1 g at weeks 20 and 28 of gestation |
1.2 | August 24, 2018—Proposed dose azithromycin as 2 g at weeks 20 and 28 of gestation |
1.3 | January 26, 2019—Addition of fourth arm |
1.4 | August 15, 2020—Addition of secondary outcomes like specimens, extended follow-ups, and neurodevelopment assessment |
1.5 | April 12, 2021—Increase in sample size based on new dropout rates due to C0VID-19 pandemic impact of health services |
1.6 | October 9, 2021—Recalculation of sample size based on TAG recommendations for multiple arm comparison |