Trial profile. *The timing of withdrawal occurred in week 2 (1 lost to follow-up), week 3 (2 lost to follow-up), week 4 (1 death, 1 lost to follow-up), week 6 (5 other interventions, 1 lost to follow-up), week 8 (1 other intervention, 1 AE), week 10 (1 lost to follow-up) for the combination treatment group and occurred in week 2 (1 lost to follow-up), week 3 (1 other intervention), week 4 (2 other interventions, 1 lost to follow-up), week 6 (1 AE, 1 other intervention, 1 lost to follow-up) for the monotherapy group.