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,p@P !$T/$1$Ifa$Eligibility verification form ( 22)xEnrolment Consent (I.a.)xInterview for non-cohort participants1 and for cohort participants interviewed > 6 months previously ( 02a)xRandomization form ( 18)xPost-randomization Information sheet (II)xSurgical consent (III)xPre-operative Interview/ Exam (03)xSurgical record (04)xPostoperative patient information sheet ( 46)xPost-operative visit forms
x...Follow up Visits 6, 12, 24 months (12)xxxAdverse Events Reporting Form (11)xxxxxProtocol deviation form (13)xxxxxxxWithdrawal form (14)xxxxxxxMissed visit form (15)xxxxxxControl subjects consent for surgery (IV)x1Men who were not previously enrolled in the cohort or cohort participants last interviewed > 6 months before enrollment will complete the interview after enrollment into the trial
Table 4. Number of AEs, exact confidence intervals and 1-sided p values for all AEs and for moderate/serious AEs.
Number of events /
Estimated rate (%)Exact 95% Confidence intervals
Exact 1-sided p-value for testing vs. 2% rate Exact 1-sided p-value for testing vs. 0.5% rate00.00-3.52 .1326.605810.05-4.92 .4033.394220.36-6.60 .5967.089830.82-7.99 .3233.014141.38-9.43 .1410.001751.99-11.03 .0508.000262.65-12.16 .0155<.00017 3.33-13.49.0041<.00018 3.52-14.84.0009<.0001
Table 5. Male HIV Incidence by Age
Age groups15-1920-2930-3940-49AllHIV Incidence/100 py in uncircumcised men (observed)1.12.11.91.81.8Estimated number of men enrolled per arm4359885824952,500
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