Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13–17 years? Findings from routine service delivery during active surveillance in Zimbabwe
Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe
Webster MavhuID 0
Sinokuthemba Xaba 1
Getrude Ncube 1
Owen Mugurungi 1
Frances M. Cowan 0
Editor: Peter M. Mugo
KEMRI Wellcome Trust Research Programme
0 Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe, 2 Liverpool School of Tropical Medicine , Liverpool , United Kingdom , 3 Population Services International (PSI) , Harare , Zimbabwe
1 Ministry of Health & Child Care , Harare , Zimbabwe
Data Availability Statement; All relevant data are within the manuscript
acceptability and satisfaction with PrePex.
Funding: The study was funded by PEPFAR
through USAID, UKAID/DFID Zimbabwe, and the
Bill & Melinda Gates Foundation through
Population Services International (PSI). The
content is solely the responsibility of the authors
and does not necessarily represent the official
views of the United States Government or United
A total of 1,811 adolescent males were circumcised across the three PrePex active
surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible.
Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed.
Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%)
mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs
resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended
7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex
from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain
associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction
Kingdom Government and the funders. The funder
had no role in study design, data collection and
analysis, decision to publish, or preparation of the
Competing interests: The authors have declared
that no competing interests exist.
with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A
majority (92%) reported experiencing pain when PrePex was being removed.
Active surveillance of the first 618 adolescent males circumcised using PrePex suggests
that the device is both safe and acceptable when used in routine service delivery among
13?17 year-olds. There is need to intensify specific demand generation activities for PrePex
male circumcision among this group of males.
Over the last 10 years, at least 14 African countries have implemented voluntary medical male
circumcision (VMMC) for HIV prevention [
]. By December 2017, a cumulative total of
18.6 million VMMCs (representing 90% of the global target of 20.8 million set in 2011) had
been performed in these countries . The 18.6 million VMMCs had already averted an
estimated 230,000 new HIV infections by 2017 and this number is projected to grow to 1.1 million
by 2030 [
]. An important innovation in the delivery of VMMC has been the introduction of
medical devices for adolescent and adult male circumcision (MC) [
]. To date, two devices,
PrePex and ShangRing, have been prequalified by World Health Organization (WHO) and
can be used in VMMC programs supported by the President?s Emergency Plan for AIDS Relief
(PEPFAR) and the Global Fund for AIDS, Tuberculosis and Malaria [
Medical devices for MC have the potential to accelerate VMMC roll-out by making the
procedure easier, quicker and more widely accessible [
]. Additionally, choice is an important
factor in enhancing acceptability and uptake of health services . VMMC devices provide an
alternative for males who are hesitant to undergo conventional surgery. During active
surveillance of the PrePex device among adult males in Zimbabwe (conducted 2014), out of 2,156
men offered VMMC, 46.4% chose PrePex over conventional surgery [
], with some citing the
desire to avoid surgery on their penis as the main reason for choosing the device.
PrePex (a device which works by compressing the foreskin between a ring and an elastic
band, leading to distal tissue necrosis) [
] received WHO full prequalification in August 2016
after being assessed as set out in WHO Framework for Clinical Evaluation of Male
Circumcision Devices [
]. Following results from studies conducted in Rwanda [
research with the device was conducted in Zimbabwe to establish its safety, efficacy and
acceptability among providers and clients [
]. Data from these studies contributed to the
prequalification of PrePex by WHO for use in adults aged 18 years . In addition to the
criteria defined in the Framework for Clinical Evaluation of Devices for Male Circumcision [
WHO also outlined an evaluation series that each country considering introduction of medical
devices for MC should complete.
The WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision
recommended active follow-up of the first 1,000 clients circumcised using a new device after
prequalification, and undertaken within the context of routine service delivery [
]. The main
purpose of the active follow-up (surveillance) is to assess safety through capturing, among
these 1,000 clients, all complications and adverse events under field (rather than research)
conditions. Zimbabwe was among the first countries to actively follow up 1,000 clients 18 years
circumcised using PrePex during routine service delivery [
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In late 2014, the WHO TAG on Innovations in Male Circumcision reviewed data on safety
and acceptability of PrePex in adolescents that were available from a bridging study involving
successful placements in 402 adolescents (13?17 years) in Zimbabwe [
]. The TAG also
reviewed partial findings from another PrePex study conducted in South Africa, which
included 89 males 13?17 years [
]. Based on findings from the two countries, the TAG
recommended that PrePex use could be extended to include eligible adolescents 13?17 years, but
only under active surveillance since the numbers assessed were small but within the range
noted in the WHO clinical evaluation framework for a bridging study . The TAG
subsequently advised that active surveillance of adolescent PrePex VMMC be undertaken .
Following the TAG recommendation, Zimbabwe actively followed up adolescents 13?17
years circumcised using PrePex during routine service delivery, where the device was
marketed through various channels including mass media (radio, television); small media
(newspaper/brochure) and; interpersonal communication (VMMC mobilizer, health-care worker).
Of note, prior to undergoing MC, all males must be screened for medical eligibility, in
particular the absence of any penile abnormalities and current genital infections [
]. With the PrePex
device, use may be further restricted due to additional anatomical reasons (e.g. phimosis?
inability to retract foreskin), a narrow foreskin opening or a short frenulum; or technical
reasons that preclude device placement (e.g. unavailability of a correct device size) [
Here, we present findings on acceptability, safety and satisfaction among all males 13?17
years circumcised using PrePex during active surveillance between October 2015 and October
Data presented here are from i) active surveillance of male adolescents consecutively
circumcised using PrePex during routine service delivery between October 2015 and October 2016
and ii) a survey conducted amongst 500 consecutive active surveillance clients to assess
acceptability and satisfaction with PrePex.
Between 19 October 2015 and 31 October 2016, PrePex circumcisions were conducted at three
VMMC clinics in Zimbabwe?s two largest provinces (Harare n = 1 clinic, Bulawayo n = 2
clinics). The three clinics had previously been sites for adult PrePex active surveillance [
VMMC staff at the three sites received refresher training on active surveillance standard
operating procedures (SOP) and data collection tools. In addition, male researchers were deployed
at the three sites specifically for data collection and client follow up.
Outcome measures for the active surveillance included i) percentage of male adolescents
seeking VMMC who opted for circumcision by PrePex rather than surgery, ii) percentage of
PrePex clients failing to return to the clinic for scheduled follow up appointment on days 7, 14
and 49, iii) percentage of PrePex clients returning to the clinic for each scheduled appointment
after receiving reminders and iv) percentage of adverse events (AEs). AEs were classified
according to the surveillance SOP and PrePex AE guidelines. Of note, early removals (i.e.
within days 1?6 of placement) requiring surgery were classified as severe AEs, the rest were
recorded as moderate AEs. Pain was assessed using a visual analogue score with possible values
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of 0, 20, 40, 60, 80, and 100 where 0 corresponded to "no pain at all" and 100 to "most severe
pain" and measured at two time points?while wearing PrePex and at removal.
Client active follow-up
During active surveillance, all male adolescents (13?17 years) seeking VMMC at the three
clinics between October 2015 and October 2016 who opted and were eligible for circumcision
using PrePex, were actively followed up for their PrePex circumcision and post-op wound
care. Clients provided their mobile phone numbers and home addresses so they could be
tracked in the event that they missed a scheduled post-circumcision appointment. In addition,
clients were instructed to return to the clinic outside scheduled appointments if they
experienced any AEs or complications with the device.
For active surveillance, if a client failed to attend for their appointment seven days post
circumcision (day 7), clinic staff made at least three attempts to contact him by phone and made
at least two home visits, if necessary. If a client failed to attend a scheduled appointment after
removal of the device (days 14 or 49), clinic staff made at least three attempts to contact him
by phone but no home visits were conducted. All missed appointments were rescheduled to a
time that was convenient to the client and consistent with clinic hours. If the client was unable
to attend, he was assessed over the phone using a standard set of questions to determine the
presence of AEs, the extent of wound healing and any wound care practices. AEs were
documented at each appointment. All attempts to contact the client were recorded on a contact log
as were reasons reported for missing the scheduled appointment. Routine VMMC monitoring
data as per national guidelines were also collected.
Five hundred consecutive active surveillance male adolescents who had undergone PrePex
male circumcision, attending for their scheduled appointment on day 14, were asked to take a
short interviewer-administered structured questionnaire. The questionnaire included
questions from other PrePex acceptability and satisfaction studies [
]. It was developed in
English and translated into Shona and Ndebele, Zimbabwe?s dominant indigenous languages,
also spoken and understood by smaller ethnic groups. It was then pretested with twenty 13?17
year-olds and subsequently refined based on their feedback. Questionnaire items explored
among others issues, reasons for choosing PrePex, satisfaction with the procedure as well as
perceptions of pain, odor and (in)convenience (S1 File).
Survey respondents were asked to indicate pain severity on a numerical scale ranging from
0 (no pain) to 100 (most severe pain). To enhance comparability of results, a pain score of at
least 60 was considered severe in line with a previous acceptability and satisfaction study
among adult men [
]. Survey respondents were also asked to indicate discomfort with odor on
a numerical scale ranging from 0 (no odor) to 100 (strongest odor). Additionally, they were
asked to indicate satisfaction with PrePex circumcision outcome on a numerical scale ranging
from 0 (no satisfaction) to 100 (highest satisfaction). The questionnaire was programmed
using Entryware software and tablets were used for data collection. Skip instructions and
mandatory data fields were used to ensure data validity, consistency and completeness. The
questionnaire was administered by trained male researchers in either Shona or Ndebele.
Data processing and analysis
Active surveillance data from the three sites were entered into a database and analyzed to
ascertain the percentage of male adolescents seeking VMMC who chose PrePex over the
surgical procedure, the percentage of PrePex clients failing to return to clinic (days 7, 14 and 49),
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the percentage of PrePex clients returning to the clinic for each scheduled appointment after
receiving reminders and, percentage of AEs.
Questionnaire data were downloaded into an Access database. Completeness and
consistency checks were performed. Any anomalies in the data were verified and corrected.
Descriptive analyses of key variables were performed. Data were analyzed using Stata 14. A
chisquared test assessed association between pain at device removal and likelihood of
recommending PrePex to others; a p-value of <0.05 was considered significant.
This acceptability and satisfaction study (plus active surveillance/secondary data use) was
approved by the Medical Research Council of Zimbabwe (A/1810) and the University College
London ethics committee (2538/003). All acceptability and satisfaction study participants
provided written informed assent in addition to caregiver consent.
Active surveillance: PrePex preference, eligibility and uptake
Between 19 October 2015 and 31 October 2016, a total of 1,811 male adolescents (13?17 years)
were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted
for PrePex but only 618/870 (71%) were eligible. Reasons for PrePex ineligibility were
adhesions/tight foreskin (n = 134/252, 53.2%), mostly in 13 and 14 year-olds (n = 125/134, 93.3%);
presence of sexually transmitted infections (n = 5/252, 2%), all in 15?17 year-olds; urinary
tract infection (n = 2/252, 0.8) and biological penile anomalies (n = 12/252, 4.8%). In 99/252
adolescents (39.3%), the available PrePex device sizes were too large, mostly in 13 and 14 year
olds (n = 86/99, 86.9%); the remainder (n = 13/99, 13.1%) were 15?16 year olds.
Active surveillance: Frequency and outcomes of follow-up
There was good adherence to follow-up appointments with 604 (97.7%) clients returning to
the VMMC site for their scheduled appointment on day 7 without the need for any reminder.
All who did not return to the VMMC site for their day 7 appointment (n = 14, 2.3%) were
successfully tracked. Of these, 13 (92.9%) returned to the VMMC clinic on day 8 after at least 2
text message reminders and 2 call attempts. All cited school commitment as their reason for
missing the scheduled appointment. The remaining client (7.1%) returned on day 9 (Monday)
after missing a pickup vehicle deployed to help circumcised males attend for follow up on day
7 (Friday). A total of 112 (18.1%) adolescents circumcised using PrePex failed to attend their
scheduled appointment on day 14, and over two thirds 423 (68.4%) failed to attend for review
on day 49. All that missed the day 49 review but were later reached by phone (n = 417, 98.6%)
reported that complete healing had been achieved.
Safety: Adverse events
Mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved
Survey: Source of information about PrePex
Between October 2015 and August 2016, 500 adolescents who had undergone PrePex male
circumcision completed an interviewer-administered questionnaire when they attended the day
14 review appointment. None among all who attended during this period declined to take part
in the study. Table 2 summarizes sources of information about PrePex (also known as the
"ring"). Most of the respondents (71.6%) said they heard about PrePex from a VMMC
mobilizer. The most-cited sources of information about PrePex were VMMC mobilizer (71.6%),
acquaintance (50.4%) and radio/television (29.6%).
Survey: Main reasons for choosing PrePex
Survey: Acceptability and satisfaction with PrePex
Satisfaction with device was high with 487 (97.4%) respondents stating that they were
satisfied/very satisfied with PrePex outcome. Device acceptability was also high with 477
adolescents (95.4%) indicating that they were somewhat likely/very likely to recommend PrePex to
peers (Table 4). Dissatisfaction was due to penile swelling after removal and transient
discoloration of the inner foreskin.
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Survey: Perceptions of pain
A total of 425 (85%) respondents reported experiencing pain whilst wearing the device (days
2?7), with 108/425 (25.4%) estimating their pain severity to be 60?100%. More than half
(n = 249/425, 58.6%) reported experiencing pain on first two days of wearing the ring, 22.8%
days 3?4 and 18.6% days 5?7. Furthermore, 460 (92%) respondents reported experiencing
pain when the device was being removed, with 155/460 (33.7%) estimating their pain severity
to be 60?100%. Of the 460 respondents, 71 (15.4%) stated that they would have opted for
surgical circumcision instead of PrePex if they had known the extent of pain. Sixty respondents
(13%) stated that they would have decided not to be circumcised at all (Table 5). Nearly
twothirds (64.6%) said they did not wish anything.
Among 23 respondents who indicated that they were not at all likely/a little likely to
recommend PrePex to their peers, 8 (34.8%) ranked their pain during device removal to be at least
60% on the numerical scale. Among 477 respondents who indicated that they were somewhat
likely/very likely to recommend PrePex to peers, 147 (30.8%), (P = 0.85) ranked their pain
similarly at 60% or above.
We present findings from active surveillance conducted among male adolescents circumcised
using the PrePex device between October 2015 and October 2016 (N = 618) during routine
service delivery in Zimbabwe. Two (0.3%) self-removals which required surgery (severe AEs),
were observed. Four (0.6%) early removals by providers due to pain (moderate AEs) did not
The low rate of severe or moderate AEs observed during active surveillance is consistent
with what was observed in adolescent PrePex research studies [
] and surveillance of the
device among adult men . Active surveillance among male adolescents suggests that PrePex
can be safely scaled up with this group in routine VMMC program roll-out. Nonetheless, the
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relatively high ineligibility rate (mostly among 13 and 14 year-olds) highlighted the need for
smaller device sizes (which are now available - http://prepex.com/prepex-newsletters). Of
note, 2% were ineligible due to presence of sexually transmitted infections (STIs), highlighting
the importance of offering VMMC to adolescents as part of a comprehensive sexual and
reproductive health package [
All six (1%) moderate/severe AEs observed during active surveillance were pain-related.
The experience of pain was also reported in the survey where 425 (85%) respondents reported
experiencing pain whilst wearing the device and 460 (92%) when the device was being
removed. This was despite a change to the analgesic protocol for PrePex VMMC clients while
wearing the device (from Paracetamol to Ibuprofen) and at device removal (application of
local anesthetic cream) [
]. Other studies have also found that the PrePex procedure is
characterized by pain [
]. VMMC programs therefore need to be honest and provide accurate
information about pain during pre-procedure counseling and conduct active pain
management as appropriate. This is particularly important since pain may result in self-removals,
likely leading to surgery. Concerning self-removals, client education needs to clearly articulate
that once placed, the device must remain in situ for seven days and if one desires to remove it,
he must return to the clinic where it may be removed with or without surgery . Most
importantly, the risks of removing the device at home should be emphasized. However, since some
early removals due to pain occur when the foreskin has already necrotized, VMMC programs
may need to offer clients the option of earlier device removal (i.e. on days 5 and 6).
Preference for PrePex during active surveillance (48%) was lower than anticipated and
lower than that of conventional surgery (52%). It had been assumed that extending the
eligibility criteria to include adolescents aged 13?17 years would increase PrePex uptake [
Given devices? potential to accelerate VMMC roll-out by making the procedure easier, quicker
and more widely accessible [
], our findings highlight the need to intensify specific demand
generation activities for PrePex male circumcision [
]. Demand creation will need to build on
the perceived comparative advantages of PrePex over conventional surgery and use these to
better sell the device.
Despite high levels of self-reported pain, acceptability and satisfaction with the device was
high among those clients who opted for it, with 95% of survey respondents indicating that they
would recommend the device to their peers, and 97% reporting satisfaction with procedure
outcome. These findings are consistent with what was observed in adolescent PrePex research
]. Ensuring that AEs, including those related to pain are accurately
communicated and managed will likely maintain these high levels of satisfaction. Of note, a higher risk
of tetanus following circumcision with PrePex compared with other circumcision methods has
been noted, and WHO has shared further recommendations for device use and tetanus
vaccination status prior to device-enabled VMMC . Moreover, post-operative wound infection
remains the most common post-procedure AE, particularly among adolescents [
due to poor post-VMMC client wound-management [
]. The need for interventions
to enhance post-VMMC wound-care can never be overemphasized. Such interventions would
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give clear instructions on genital hygiene and wound-care, emphasize the benefits of
prophylactic tetanus vaccination, and underscore the dangers of applying traditional medicines and
substances to wounds [31, 38]. While the recommendation to restrict PrePex to individuals
sufficiently vaccinated against tetanus has tremendously reduced the number of
PrePexenabled procedures [
], there might be opportunities for the device to be introduced in
school-based VMMC programs in combination with accompanying vaccination initiatives.
As with surveillance among adult men [
], there was high adherence (98%) to the scheduled
day 7 appointment. Similar follow-up rates to adults were observed on day 14 (82% vs. 80)
with lower follow up at day 49 (32% vs. 50%)?despite text message reminders and call
attempts. The sub-optimal attendance on day 49 is consistent with previous observations [
Among adolescents, this may also be explained by reliance on program pickup vehicles plus
the inability to meet the transportation costs involved (at least 1US$ each round trip). Indeed,
transportation costs have been reported as the largest out-of-pocket expenditure incurred by
VMMC clients [
]. Given the sub-optimal adherence to the day 49 follow-up appointment,
the absence of any AEs during this period, and subsequent assurances by clients reached by
phone that complete healing had been achieved, reviewing the post-circumcision follow-up
protocol will not only reduce the number of scheduled appointments but associated expenses
as well. Importantly, programs should continue to offer the minimum package of VMMC at
each visit including HIV testing, HIV prevention counseling, screening/treatment for STIs,
condom promotion, and the VMMC procedure [
Finally, participants indicated that they had mostly learned of PrePex from mobilizers and
acquaintances, suggesting the effectiveness of interpersonal communication in creating
demand for VMMC in general and PrePex-led VMMC, in particular. The success of these
participatory approaches in motivating males of all ages to take up VMMC has been reported in
other regional settings [
]. These approaches therefore need to be intensified if fast track
] are to be achieved. Of note, only a few had learned of PrePex from health-care
workers, reflecting the well-recognized males? general avoidance of the formal health system [
Indeed, VMMC is one of the few entry points through which health services can reach male
A potential limitation of the findings presented here is that only the males who returned for
the day 14 visit were interviewed and therefore, they may not be representative of the entire
population that was circumcised using PrePex. Additionally, this active surveillance was
limited to 618 adolescents. We had anticipated that surveillance would include 1,000 adolescents
and that this number of PrePex circumcisions would have been performed within <12
months. However, uptake was much slower than anticipated and we did not have resources to
continue active surveillance beyond 12 months. In addition, WHO had gathered sufficient
evidence to recommend that use of the PrePex device could be extended to eligible adolescents
13?17 years in August 2016 [
], making it unnecessary to continue in surveillance. This is,
however, one of the first initiatives to actively follow up male adolescents circumcised using
PrePex during routine service delivery. Findings will likely inform VMMC programs as they
scale up device-led adolescent VMMC in general and adolescent PrePex VMMC, specifically.
We successfully followed up the first 618 male adolescents circumcised using PrePex during
routine service delivery, and surveyed 500 of them to determine device safety as well as
acceptability and satisfaction. Despite high levels of self-reported pain, we found that PrePex is both
9 / 13
safe and acceptable when used in routine service delivery among male adolescents (13?17
years). Findings highlight the need to intensify specific demand generation activities for
PrePex male circumcision among this group of males. Recently-introduced smaller device sizes
will partly address the high ineligibility observed so far. Lastly, these data suggest that it may
not be necessary to continue to advise males to return to the clinic 49 days after they have been
S1 File. Study questionnaire.
We thank study participants for making this study possible. We also thank staff at the three
PrePex active surveillance sites and data collectors for implementing the active surveillance
standard operating procedures.
Conceptualization: Webster Mavhu, Karin Hatzold, Ngonidzashe Madidi, Brian Maponga,
Roy Dhlamini, Sinokuthemba Xaba, Getrude Ncube, Owen Mugurungi, Frances M.
Data curation: Webster Mavhu, Malvern Munjoma.
Formal analysis: Webster Mavhu, Malvern Munjoma.
Funding acquisition: Karin Hatzold, Ngonidzashe Madidi, Brian Maponga, Sinokuthemba
Xaba, Getrude Ncube, Owen Mugurungi, Frances M. Cowan.
Investigation: Webster Mavhu.
Methodology: Webster Mavhu, Karin Hatzold, Ngonidzashe Madidi, Brian Maponga, Roy
Dhlamini, Malvern Munjoma, Sinokuthemba Xaba, Getrude Ncube, Owen Mugurungi,
Frances M. Cowan.
Project administration: Webster Mavhu, Roy Dhlamini.
Resources: Karin Hatzold, Ngonidzashe Madidi, Brian Maponga, Roy Dhlamini,
Sinokuthemba Xaba, Getrude Ncube, Owen Mugurungi, Frances M. Cowan.
Supervision: Webster Mavhu, Roy Dhlamini, Frances M. Cowan.
Validation: Webster Mavhu, Karin Hatzold, Ngonidzashe Madidi, Brian Maponga, Roy
Dhlamini, Malvern Munjoma, Sinokuthemba Xaba, Getrude Ncube, Owen Mugurungi, Frances
Visualization: Malvern Munjoma.
Writing ? original draft: Webster Mavhu.
Writing ? review & editing: Karin Hatzold, Ngonidzashe Madidi, Brian Maponga, Roy
Dhlamini, Malvern Munjoma, Sinokuthemba Xaba, Getrude Ncube, Owen Mugurungi, Frances
10 / 13
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WHO. Tetanus and voluntary medical male circumcision: risk according to circumcision method and
risk mitigation. Report of the WHO Technical Advisory Group on Innovations in Male
Circumcision?consultative review of additional information, 12 August 2016. Geneva: WHO, 2016.
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