Two-year Evaluation of a Variable-Thread Tapered Implant

in Extraction Sites with Immediate Temporization:

A Multicenter Clinical Trial
Bradley S. McAllister, DDS, PhD1/James E. Cherry, DMD2/Martin L. Kolinski, DDS3/
Kenneth D. Parrish, DDS, PhD4/David W. Pumphrey, DDS5/Robert L. Schroering, DMD4

Purpose: The purpose of this clinical trial was to evaluate the survival rate, bone remodeling, and soft
tissue health surrounding variable-thread tapered implants placed in fresh extraction sites and loaded
immediately. Materials and Methods: Sixty implants were placed in 55 patients at six centers according to
a predetermined protocol. All implants were placed in extraction sockets and were subjected to immediate
temporization. Definitive prostheses were placed within the first year. Clinical and radiographic examinations
were performed at implant placement and after 3, 6, 12, and 24 months. Assessments of implant stability,
Papilla Index, plaque, peri-implant mucosa, and marginal bone levels were performed at the respective
visits. Results: Fifty-five patients were treated and were restored with 58 single crowns and 1 two-unit
fixed partial prosthesis. The cumulative survival rate was 98.3% after 2 years. One implant failed prior to
3 months. The mean marginal bone remodeling from implant insertion to 1 year was –0.22 ± 1.30 mm (n
= 41), followed by an average bone gain of 0.12 ± 0.77 mm (n = 33) between 12 and 24 months. Mean
marginal bone remodeling was –0.10 ± 1.38 mm (n = 35) from implant insertion to 2 years. Papilla size
increased significantly over the 2-year study period. Patient assessments of function, esthetics, and self-
esteem also showed significant improvement. Conclusion: The 24-month results indicate that the variable-
thread tapered implant can be used safely and effectively under demanding conditions as an immediate
postextraction tooth replacement. Int J Oral Maxillofac Implants 2012;27:611–618.

Key words: dental implant, extraction socket, immediate loading, variable threading

O sseointegrated dental implants are considered to

be an accepted means of providing a predictable
outcome for the replacement of missing or soon-to-
be-extracted teeth. A literature review of 31 articles1
showed that the survival rates of implants placed in
extraction sites are comparable to those of implants
placed in healed ridges. The authors of the review
concluded that, along with the benefit of being less in-
vasive, such treatment also contributes to the preser-
vation of the volume and anatomy of the original soft
and hard tissues.
1Private
Practice Limited to Periodontics, Tigard, Oregon.
2Private
Practice Limited to Oral and Maxillofacial Surgery,
Jacksonville, Florida.
3 Private Practice Limited to Periodontics, St Charles, Illinois.
4Private Practice Limited to Periodontics, Louisville, Kentucky.
5Private Practice Limited to Periodontics, Atlanta, Georgia.
Correspondence to: Dr Bradley S. McAllister, 11525 SW
Durham Rd, Suite D-6, Tigard, OR 97224. Fax: +503-968-5419.
Email: mcallister@portlandimplantdentistry.com
Advances in techniques and materials, along with
patient demand for shorter treatment time, fewer
surgical sessions, and reduced costs, have paved the
way for immediately placed implants to be placed into
immediate function.2 Numerous studies have shown
that, with sufficient primary stability, immediate im-
plants in extraction sockets that are placed into imme-
diate function can also have successful results.3–10
Early implant stability, which is crucial for the success
of implants placed into extraction sockets and imme-
diately loaded, can be affected by both the implant’s
surface chemistry and by its geometric design. The
variable-thread tapered implant examined in the pres-
ent study (NobelActive, Nobel Biocare) was designed
to optimize the osseointegration process (see Fig 1a).
The TiUnite surface (Nobel Biocare) is an oxidized,
highly crystalline, phosphate-enriched titanium diox-
ide surface that has been demonstrated to preserve
primary implant stability and reduce the risk of failure
(compared to machined-surface implants) with imme-
diate loading protocols.11–16 A comparison of machined

The International Journal of Oral & Maxillofacial Implants 611

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McAllister et al
and rough-surfaced implants placed in extraction
sites showed higher success rates for the implants with
a rough surface.17 Macroscopic grooves have also been
placed on the threads of the NobelActive implant. Bone
formation has been shown to occur faster within the
grooves, which results in faster osseointegration of the
implant and increased early stability compared to im-
plants without the groove.18
The threads of this novel implant were designed to
provide high insertion torque. The implant acts as an
osteotome, condensing the bone as it is being placed.
The spacing between the threads increases toward the
coronal end of the implant, allowing for axial and ra-
dial bone compression during implant insertion. This
can be especially useful in areas of minimal bone qual-
ity or quantity and can provide the increased primary
stability that is necessary for immediate loading. The
implant also has a built-in platform switch occurring
at the bone level. This is enabled by use of an internal
conical connection that allows for increased soft tissue
preservation by providing a secure internal prosthetic
interface along with a narrow emergence profile. This
concept of placing a smaller-diameter abutment on
a wider-diameter platform has been shown to have
positive effects on the hard and soft tissue remodeling
that is seen around dental implants.19–22
The primary objective of the present ongoing study
was to determine the survival rate of this novel implant
when used for immediate placement in extraction
sites and to evaluate bone levels and soft tissue health
at the implant sites over time.
Materials and methods
Patient Selection
The present analysis was an open, multicenter, pro-
spective study. The results represent the 2-year fol-
low-up data of a planned 3-year study. The study was
designed in accordance with the Belmont Report of
1979. Approval for the study was obtained by an ethi-
cal review committee (Independent Review Consult-
ing; approval 07173-03) for all participating centers.
Subjects in need of an implant-supported fixed resto-
ration placed in an extraction site (immediate place-
ment) were asked to participate in the clinical trial.
Informed consent was obtained from all subjects on
a written form approved by the ethical committee. All
subjects were provided with oral and written informa-
tion about the purpose of the trial, the clinical proce-
dures, materials used, and the risks of and alternatives
to the proposed therapy. Those subjects who fulfilled
the inclusion criteria, expressed interest in participat-
ing, and provided written informed consent were in-
cluded in the study.
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All participating subjects met the following inclu-
sion criteria: (1) a need for an implant-supported, fixed
restoration in an extraction site; (2) sufficient bone vol-
ume and density to receive implants with a diameter of
3.5 mm and a length of at least 10 mm; (3) an extraction
socket with at least three intact walls (a dehiscence de-
fect of up to 3 mm was permitted on the fourth wall);
(4) fulfillment of criteria for immediate temporization
at the implant site, ie, a minimum of 35 Ncm of torque
without further rotation, and the absence of tooth
remnants; (5) good health and compliance with good
oral hygiene; (6) a stable occlusal relationship with no
pronounced bruxism; and (7) availability for the entire
3-year term of the investigation.
A subject was not admitted to the study if any of the
following existed: (1) alcohol or drug abuse, as noted
in the subject’s records or medical history; (2) health
conditions that would preclude surgical procedures;
(3) any pathologic conditions in the planned implant
area such as previous tumors, chronic bone disease, or
previous irradiation; (4) any psychiatric disease or relat-
ed problem, as noted in the patient’s records or medi-
cal history, that might have a negative effect on the
subject’s overall situation; (5) severe bruxism or any
other destructive parafunction; (6) inability to provide
informed consent; (7) a need for bone augmentation
prior to implant insertion to obtain an ideal position
for the implant(s), although a minor augmentation
procedure to cover exposed threads or interproxi-
mal/buccal grafting owing to hard tissue deficiency
was not an exclusion criterion; (8) ongoing infectious,
endodontic, or periodontal problems associated with
teeth in positions adjacent to the extraction site; and
(9) inability of the implant to withstand a final torque
of 35 Ncm without further rotation.
All participants who met the criteria for study inclu-
sion underwent a pretreatment examination in which
patient data and medical history were documented
thoroughly. Patients were selected between November
2007 and June 2008.
Surgical and Prosthetic Protocols
The study protocol called for a variable-thread tapered
implant (NobelActive implants, Nobel Biocare) to be
placed in fresh extraction sites and immediately load-
ed with a provisional restoration. The implants for the
study were available in lengths of 10 mm, 11.5 mm,
13 mm, and 15 mm, as measured on the threaded
part of the implant. The available diameters were
3.5 mm, 4.3 mm, and 5.0 mm, although no 3.5-mm im-
plants were selected for insertion in the study patients.
Abutments for the implants were available in narrow-
platform and regular-platform (RP) configurations.
The RP abutments were used for both the 4.3-mm and
5.0-mm implants because of the implant’s platform

Fig 1a (Left)  Diagram of variable-thread implant. Arrow indi-
cates the reference point.
Fig 1b (Right)  Periapical radiograph of a variable-thread im-
plant in situ.
shifting design. All components used in the study had
received proper regulatory clearance from the US Food
and Drug Administration.
Pre- and postoperative medications were admin-
istered according to the clinical protocols of the re-
spective study center. The surgical procedure was
performed according to the implant manufacturer’s
guidelines (Nobel Biocare CFB and SFB Self-Cutting
Implant Systems, Surgical and Prosthetic Manual,
GEN 53513/03). All implants were placed by dentists
experienced in the field of implant dentistry, and all
participating clinicians received individual training
at their clinic. The implants were placed in extraction
sockets immediately after tooth extraction. A single-
stage surgical approach with immediate provisional-
ization was utilized. Implants needed to be clinically
stable, as judged by the clinician, and provisionalized
within 24 hours of surgery. Insertion torque was mea-
sured using a manual torque wrench (0- to 150-Ncm
range, Nobel Biocare). Using a modification of criteria
suggested by van Steenberghe,23 a “surviving implant”
was defined as an implant that remained in the jaw
and successfully functioned as planned, and a “failed
implant” was defined as an implant that had been re-
moved, fractured beyond repair, or could not be classi-
fied as surviving.
Bone quality and quantity were assessed at each
implant site according to the Lekholm and Zarb clas-
sification.24 Papilla contour was assessed according to
the Jemt Papilla Index.25 Following implant placement,
all subjects were provided with home care mainte-
nance instructions and were scheduled for postopera-
tive checkups on an individual basis.
Follow-up Evaluations
Clinical follow-up examinations were performed at 3
months, 6 months, 1 year, and 2 years after implant
insertion. Implants were classified as stable, having
rotational mobility, or requiring removal. Soft tissue
esthetics were again assessed with the Jemt Papilla
Index.25 The status of the peri-implant mucosa was
evaluated according to a modified version of the Löe
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McAllister et al
Reference
point
and Silness26 Gingival Index and registered as normal,
bleeding on superficial probing, or spontaneous bleed-
ing. Plaque was assessed as either no visible plaque or
visible plaque using a modified version of the Silness
and Löe Plaque Index.27 For all parameters, the mea-
surements obtained at implant insertion served as the
baseline measurements for comparison over the study
period.
Crestal bone levels around the implants were as-
sessed with evaluation of intraoral radiographs by an
independent radiologist. Radiographs were made us-
ing a long-cone paralleling technique28 at the time of
implant insertion (baseline measurement) and at each
follow-up visit. Each center used digital radiograph sys-
tems with an exposure time that was appropriate for
each system. All radiographs were evaluated digitally.
The marginal bone level, defined as the position of the
most apical bone-to-implant contact point as compared
to the reference point on the implant, was evaluated.
Radiographs were displayed using computer software
(Illustrator CS3, version 13.0.2, Adobe Systems) on a
24-inch monitor (iMac, Apple) with a screen resolution
of 1,920 × 1,200 pixels. The measuring tool built into
the software was used to calculate the measurements
(with magnifications taken into account). The observers
adjusted the brightness, contrast, and zoom of the im-
ages to achieve the best possible measurement condi-
tions. The reference point (Fig 1a) used for the readings
was the coronal shoulder at the top of the implant. The
distance from the reference point to the bone level was
recorded both mesially and distally, and a mean value
was calculated for each implant (for example, Fig 1b
shows a distal reading of –0.7 mm and a mesial read-
ing of 0.0 mm). The esthetic and functional outcome of
the restorations was evaluated, subjectively, based on a
visual analog scale29 (VAS) completed by subjects at the
pretreatment visit, implant insertion, and at the 1- and
2- year follow-up visits. The scale ranged from “poor” = 0
to “excellent” = 100, with “average” = 50. Cumulative
survival rates were calculated by an actuarial life table
method.30 The dentists were also asked to evaluate
their experience while placing the implants.
The International Journal of Oral & Maxillofacial Implants 613
McAllister et al

Table 1  Implant Placement

Maxillary position, US (FDI)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
(18) (17) (16) (15) (14) (13) (12) (11) (21) (22) (23) (24) (25) (26) (27) (28) Total
No. of – – – 1 8 4 4 12 10 0 1 5 7 – – – 52
implants
Mandibular position, US (FDI)
32 31 30 29 28 27 26 25 24 23 22 21 20 19 18 17
(48) (47) (46) (45) (44) (43) (42) (41) (31) (32) (33) (34) (35) (36) (37) (38) Total
No. of – – – 2 1 – – – – – – – 1 1 3 – 8
implants

Table 2  Diameters and Lengths of Table 3   Bone Quality and Quantity at
Implants Placed (Failed) Implant Sites24
Diameter/length Maxilla Mandible Quality
4.3 mm Quantity 1 2 3 4 Total
10 mm 2 0 A 0 19 18 0 37
11.5 mm 1 1 B 0 8 12 (1) 0 20 (1)
13 mm 16 1 C 0 1 1 0 2
15 mm 24 (1) 3 D 0 0 1 0 1
Total 43 (1) 5 E 0 0 0 0 0
5.0 mm Total 0 28 32 (1) 0 60 (1)
10 mm 1 0 Numbers within parentheses indicate failed implants.
11.5 mm 0 0
13 mm 4 3
15 mm 4 0
Total 9 3
Overall total 52 (1) 8

Results Subject age at time of surgery ranged from 19 to

A total of 55 subjects (31 women, 24 men) were treated
consecutively at six participating clinics. Two addition-
al subjects were enrolled but not included in the study
because the insertion torque did not reach the required
minimum of 35 Ncm. Data for withdrawn subjects up
to the time of withdrawal are included in the analysis.
Twelve subjects (corresponding to 14 implants) with-
drew over the 2-year period, 11 for noncompliance or
relocation out of state and 1 because the study im-
plant was lost. Attempts were made to contact the 11
patients but were unsuccessful. There is no knowledge
of any problems related to these implants. Fifty-three
subjects attended the 3-month follow-up, 50 attended
the 6-month follow-up, 48 attended the 1-year follow-
up, and 43 subjects have been followed for at least
2 years, although four of these were seen at 3 years and
had missed their 2-year appointment. All but one sub-
ject have been restored with definitive prostheses.
82 years, with a mean of 52.6 ± 13.3 years (n = 55).
The mean ages of the women and men were 50.1 and
55.9 years, respectively. Between November 2007 and
June 2008, a total of 60 implants was included in the
study; 52 (87%) were in the maxilla and 8 (13%) were
in the mandible (Table 1). The distribution of implant
diameters and lengths is shown in Table 2.
All of the implants were placed in bone quality of
type 2 (47%) or type 3 (53%). Bone quantity was as-
sessed as type A or B for 95% of the implants (Table
3). Forty-eight implants (80%) were reported to have
been placed with some cortical anchorage, while 12 im-
plants (20%) were not anchored by either cortical plate.
Forty-two implants (70%) were placed in areas of normal
buccal mucosal thickness, 7 (12%) were judged to have
thin mucosa, and 11 (18%) were judged to be thick mu-
cosa. Twenty-one (35%) sites had shown chronic infec-
tion that led to the extraction; only one site (2%) had
an acutely infected area. Thirty-eight (63%) sites had no

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 McAllister et al

Table 4  Insertion Torque (Ncm) of Table 5  Life Table Analysis

Implants Placed No. at No. No. CSR
Insertion torque No. of implants % of implants Time risk failed withdrawn (%)

35 12 19 Insertion to 3 mo 60 1 1 98.3

40 5 8 3 to 6 mo 58 0 4 98.3

45 6 10 6 mo to 1 y 54 0 3 98.3

50 20 32 1 to 2 y 51 0 5 98.3

55 0 0 2 y+ 46

60 2 3 CSR = cumulative survival rate.

65 0 0
70 15 24

100 Papilla
Mean marginal bone level (mm)

0.0 scores:
80 1
2

Papilla score (%)

–0.5 3
60
4
–1.0
40

–1.5 20

–2.0 0
0 6 12 18 24 Insertion 3 mo 6 mo 12 mo 24 mo
Follow-up (mo) Time

Fig 2   Mean marginal bone levels over time for implants with Fig 3   Papilla scores of implants over time.
readable radiographs at all follow-up appointments (n = 35).
Error bars indicate 95% confidence intervals.

infection. For 55 of the implants (92%), minor bone aug-
mentation was performed to cover the exposed threads
or for interproximal/buccal grafting. Bio-Oss (Osteo-
health), Regenafil (Exactech Inc), Oragraft (LifeNet
Health), and PepGen P-15 (Dentsply-Friadent) were
used in 98% of these cases, and one case was treated
with Puros (Zimmer Inc). The mean insertion torque was
50.0 ±12.7 Ncm (Table 4). Fifty-eight (97%) of the im-
plants were placed as single-tooth replacements, and
implants (3%) were part of a fixed partial restoration. All
definitive restorations were placed within a window of
3 to 12 months following implant insertion.
Only one implant failure was observed during the
2-year follow-up period. This implant had to be re-
moved at the 3-month follow-up appointment be-
cause of infection of unknown origin, and the patient
was withdrawn from the study. The resulting cumula-
tive survival rate was 98.3% at 2 years (Table 5).
The marginal bone remodeling from implant inser-
tion to the 2-year follow-up is presented in Table 6.
Between insertion and 1 year, 41 implants showed
a mean bone loss of 0.22 ± 1.30 mm. Between im-
plant insertion and 2 years, the 35 surveyed implants
showed a mean loss of 0.10 ± 1.38 mm of bone. Bone
levels increased by an average of 0.12 ± 0.77 mm be-
tween the 1-year follow-up and the 2-year follow-up
(n = 33). Marginal bone levels observed over time are
shown in Fig 2. All implants were reported stable at the
6-month, 1-year, and 2-year follow-up examinations.
The distribution of papilla scores (mesial + distal/2)
at different time points is shown in Fig 3. Papilla scores
increased significantly (P < .001; Wilcoxon signed rank
test) between insertion and the 2-year follow-up, with
most of the increase occurring during the first year. An
increase in mean papilla scores was seen for 69.2% of
evaluated papillae, while a decrease was seen in only
one subject (2.6%). The percentage of implant sites
with plaque (89% to 95%) and bleeding on probing
(92% to 98%) remained stable over the 2-year evalu-
ation period.

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McAllister et al
100
90
80
70
Mean VAS score
60
50
40
30
20
10
0
Pretreatment Implant Definitive
insertion prosthesis
delivery
No serious adverse events have been reported to
date. Nonserious device-related adverse events includ-
ed implant failure as a result of mobility (n = 1), along
with recession (n = 2), swelling (n = 1), and drainage
(n = 1). Both the drainage and the swelling had sub-
sided by the time of the next follow-up visit.
Mean subject ratings for function, esthetics, and
self-esteem prior to treatment ranged from 58.9 (es-
thetics) to 68.7 (self-esteem). At the time of implant
insertion, the mean values had increased to a range
of 63.6 (function) to 84.2 (self-esteem). At the 2-year
follow-up, the mean scores were 94.4 ± 8.13 for func-
tion, 83.3 ± 13.59 for esthetics, and 91.2 ± 11.15 for
self-­esteem (Fig 4). All scores increased significantly
(P < .014; Wilcoxon signed rank test) between implant
insertion and the 2-year follow-up.
All clinicians were asked to evaluate their experi-
ence with the NobelActive implant. Forty-four percent
of the implant surgeries utilized the “redirection” fea-
ture of the implant, an option in which the clinician
can redirect the axis of implant placement during
insertion. In one case, the lingual plate prevented its
use, and in one instance there was not enough palatal
bone present to redirect the implant. The remainder of
surgeries indicated no need for this function. In 93% of
the cases, the clinician indicated that they were able
to position the implant as planned. Two implants had
to be placed more deeply than anticipated to achieve
initial stability, one implant had to be moved more
palatally than desired, and in only one case was the
clinician unable to change the angulation of the im-
plant. In 82% of cases, where initial insertion was not
optimal, the clinician was able to remove the implant
and correct its position/direction.
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Fig 4   Patient satisfaction scores
over time, as indicated by the VAS.
Function
Esthetics
Self-esteem
1y 2y
Discussion
The results of the present study indicate that the vari-
able-thread tapered implant can be used as a successful­
and predictable implant, even under demanding con-
ditions such as an immediate postextraction tooth
replacement with immediate provisional loading. The
procedure requires the appropriate insertion condi-
tions as well as an experienced clinician to judge the
conditions and perform the surgery. The technique
should be limited to cases that can be placed in a po-
sition that meets the requirements for initial stability
without adversely affecting esthetics. In this study, two
implants did not meet insertion torque requirements,
and two implants were included even though they
had to be placed deeper than suggested to reach the
minimal torque. To the author’s knowledge, only one
implant has failed; this took place early in the first year
of the study and resulted in an overall survival rate
of 98.3% over 2 years (Table 5). This is comparable to
studies in which similar implants were used in healed
sites under similar loading conditions.31–34
The variable-thread implant was designed to pro-
vide high initial stability, presumably making the
implant more effective for immediate placement in
extraction sockets. The implant has a 1.2-mm thread
spacing, which causes the implant to advance 2.4 mm
with each rotation (according to the manufacturer);
this is much higher than conventional implants. The
high thread pitch requires more torque at insertion.
The mean insertion torque for the implants placed in
the study was 50 ± 12.7 Ncm (n = 60), similar to the
torque reported by Kielbassa et al.31 This compares to
reports of less than 20 Ncm for other implants used in
soft or poor-quality bone.35,36

Table 6   Marginal Bone Remodeling (Bone Loss)
Insertion–1 y
Amount of
remodeling (mm) n %
>0 11 27
0 5 12
–0.1 to –1.0 17 42
–1.1 to –2.0 5 12
–2.1 to –3.0 1 2
–3.1 to –4.0 2 5
Bone remodeling data from all available radiographs. Average amount of remodeling is shown
(mesial + distal)/2. Negative numbers indicate bone loss.
Measurement of crestal bone levels is often con-
sidered as a marker of treatment success. The present
study revealed less bone remodeling over the first year
compared to studies of conventional implants used in
similar circumstances,37,38 and approximately 50% of
the early loss (which occurred between the 1-year and
2-year follow-up examinations) was recovered (Table 6).
It should be noted that the radiographic bone level
findings in this study were limited to immediate im-
plant placement and loading where a bone graft was
typically employed. Different bone grafting materials
may have affected the apparent radiographic determi-
nation of the bone levels, and placement in mature na-
tive bone may have shown a different outcome. Some
radiographic readings were approximated by the radi-
ologist because of inadequate quality of the images.
This was the case for the two implants that were re-
ported to have lost between 3 and 4 mm of bone in the
first year. Both of these implants remained in the study
and were reported to have regained some of the lost
bone during the second year.
The mean papilla score increased during both the
first and second years of the study (Fig 2). This was in
agreement with the recent study by Kielbassa et al, in
which the implant was placed more conventionally in
healed sites.31 These results could be attributable to
the implant’s surface and its built-in platform switch-
ing but were also probably influenced by the favorable
crestal bone height.
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McAllister et al
Insertion–2 y 1 y–2 y
n % n %
12 34 16 49
4 11 3 9
10 29 11 33
7 20 3 9
2 6 0 0
0 0 0 0
Conclusion
Within the limitations of this study, stable bone and
soft tissue levels were seen around the tested variable-
thread implant after 2 years in function, indicating that
the implant can be used safely and effectively under
the demanding conditions of immediate loading of
implants placed in fresh extraction sockets. However,
long-term follow-up analyses are needed to evaluate
function over time, and continuing follow-up is indi-
cated to confirm the results of this study.
Acknowledgments
This trial was supported by Nobel Biocare Services AG, Kloten,
Switzerland (grant T-122B). The authors are grateful to the sub-
jects for their kind cooperation and want to thank all persons
who were involved in the implementation of the present trial.
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