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Contraception 88 (2013) 730–736 Original research article Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial☆,☆☆,★ Rebecca H. Allen⁎, Christina Raker, Vinita Goyal Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI 02905, USA Received 2 May 2013; revised 15 July 2013; accepted 26 July 2013 Abstract Objective: To determine the effectiveness of 6 mL of 2% lidocaine cervical gel for pain during intrauterine device (IUD) insertion. Study Design: This is a randomized double-blind placebo controlled trial of 6 mL of 2% lidocaine gel for IUD insertion pain among first- time IUD users. No other analgesia other than the study intervention was provided. The study was conducted at a university-based obstetrics and gynecology clinic. The primary outcome, pain during IUD insertion on a 0 to 100-mm visual analog scale, was analyzed using the t test. Results: Seventy-three women received placebo gel, and 72 women received 2% lidocaine gel. The groups had similar sociodemographic and clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine group reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p=.4). Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median 36) in the placebo group (p=.8). Conclusions: Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel. Implications: Among first-time IUD users, including both nulliparous and multiparous women, 6 mL of 2% lidocaine gel placed on the anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel. © 2013 Elsevier Inc. All rights reserved. Keywords: Pain; Intrauterine device; Intrauterine system; Anesthesia 1. Introduction As of 2008, only 5.5% of women using contraception in the United States reported relying on the intrauterine device (IUD) [1]. Increased use of IUDs is desirable because the method is a safe, highly effective, long-acting means of contraception that reduces unintended pregnancies [2,3]. One barrier to IUDs for contraception is the fear of pain during insertion [4]. Components of the insertion procedure that may cause pain include the tenaculum applied to the cervix to straighten the cervical canal and passing the uterine sound and IUD inserter tube through the internal os of the ☆ Source of funding: The Society of Family Planning Grant SFP4-4. ☆☆ Financial Disclosures: None. ★ ClinicalTrials.gov Identifier: NCT01292447. ⁎ Corresponding author. Tel.: +1 4012741122x2724; fax: +1 40153 7684. E-mail address: rhallen@wihri.org (R.H. Allen). 0010-7824/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.contraception.2013.07.009 cervix [5]. Immediately after placement, the IUD may stimulate myometrial contractions causing pain [5]. Factors associated with pain during IUD insertion include nulliparity, lengthier time since last pregnancy or last menses, history of dysmenorrhea, anticipated pain, not currently breastfeeding and older age [6–11]. Studies have shown that up to 21.3% of nulliparous women report severe pain during IUD insertion, and nulliparous women report greater pain during IUD insertion than multiparous women [6,7,11]. There are no proven interventions for pain control during IUD insertion [12]. Although widely used, both 400 mg and 800 mg of ibuprofen prior to insertion are ineffective [7,13]. Misoprostol also fails to provide decreased pain during IUD insertion [14,15]. Topical 2% lidocaine gel on the cervix is another option for pain control for IUD insertion. This is employed in the UK but has not been adopted widely in the US [16,17]. One early trial in 1996 showed decreased pain with 6 mL of 2% lidocaine gel; however, that study lacked http://dx.doi.org/10.1016/j.contraception.2013.07.009 http://dx.doi.org/10.1016/j.contraception.2013.07.009 http://dx.doi.org/10.1016/j.contraception.2013.07.009 mailto:rhallen@wihri.org http://dx.doi.org/10.1016/j.contraception.2013.07.009 731R.H. Allen et al. / Contraception 88 (2013) 730–736 proper blinding and allocation concealment [12,17]. Since lidocaine gel does not require an injection, it may be pre- ferable to a paracervical block, which can be painful to administer. In fact, in one study, a 10-mL 1% lidocaine paracervical block did not result in a statistically significant decrease in pain with IUD insertion [18]. However, this same study did show a decrease in pain with tenaculum placement after 2 mL of 1% lidocaine was injected into the anterior lip of the cervix. Two more recent randomized placebo- controlled trials have failed to find that 2% lidocaine gel applied to the cervix decreased pain with IUD insertion. The first trial used 1 mL of gel applied to the internal os of the cervix with a cotton swab for 1 min for a dose of 20 mg of lidocaine [10]. In the second trial, all subjects received 800 mg of ibuprofen and 0.5–1 mL of gel on the anterior lip of the cervix as well as 2–3 mL of gel at the internal os for 3 min for a dose of 50 mg to 80 mg of lidocaine [19]. The purpose of this study was to test the efficacy of 3 mL of 2% lidocaine at the anterior lip of the cervix and 3 mL in the cervical canal for 3 min for pain control with tenaculum placement and IUD insertion. This lidocaine dose, 120 mg, and application protocol are identical to the 1996 study by Oloto et al. Our aim was to replicate this study in a proper randomized, placebo-controlled trial to determine the effec- tiveness of 2% lidocaine gel. We chose a 3-min waiting period to allow for the absorption of topical lidocaine gel. The product information for 2% lidocaine gel states that 3 to 5 min is required for absorption [20]. We also sought to describe participant satisfaction with pain control and any side effects associated with 2% lidocaine gel. 2. Materials and methods We conducted a randomized, double-blind, placebo- controlled trial at a university obstetrics and gynecology practice in Providence, RI, from March 2011 to July 2012. The Women and Infants Hospital Institutional Review Board granted approval for the study protocol, and all patients provided written informed consent. English or Spanish- speaking women 18 to 49 years old requesting IUD insertion for contraception or abnormal uterine bleeding were approached for participation. Inclusion criteria included no prior IUD use, more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant, no analgesics or anxio- lytics in the previous 12 h and no misoprostol use prior to insertion. Exclusion criteria included any contraindication to IUD placement, allergy to lidocaine or sensitivities to com- ponents of the lidocaine or placebo gel and chronic narcotic, benzodiazepine or barbiturate use within the past year. Sub- jects chose the type of IUD desired, either the CuT380A IUD or the levonorgestrel IUD. After consent and study enrollment by study staff, par- ticipants were randomized to one of two groups, 2% lidocaine gel or placebo gel (KY Jelly) in a 1:1 ratio. Ran- domization lists were centrally computer generated with a one-to-one allocation ratio in alternating blocks of four and six by the Women and Infants pharmacy staff. According to the randomization list, the pharmacy prepared identical syringes containing 6 mL of the 2% lidocaine gel (120 mg) or placebo gel labeled only with the study name and se- quentially numbered. The study gels were indistinguishable in appearance. Each participant was assigned a study ID number corresponding with the order of recruitment into the study. No identifiers of treatment group were placed on subject data sheetsor medications, only the study number in order of enrollment. Both subjects and providers were blind to treatment assignment. After randomization, we surveyed participants with a preprocedure questionnaire assessing self-reported race, ethnicity and primary language; self-assessment of pain tolerance; ratings of anticipated and acceptable levels of pain on the 0- to 100-mm visual analog scale (VAS); lactation status; current contraception (if any); last menstrual period; and any history of cervical conization (loop electrosurgical excision procedure or cold knife cone). In order to measure dysmenorrhea, women were also asked if their menses in the last 3 months were associated with any pain (no pain, slight pain, moderate pain, severe pain and very severe pain) or if recently pregnant and if their menses in the 3 months prior to pregnancy were associated with any pain. We administered the State-Trait Anxiety Inventory for Adults to assess baseline anxiety at the time of IUD insertion [21]. Obstetric history was also obtained from subjects and the medical record including date of last pregnancy, mode of past deliveries and, if cesarean, whether scheduled (no labor) or after a trial of labor, including the number of centimeters of dilatation achieved. In addition, subject descriptors including age, type of health insurance, height and weight were abstracted from the medical record. IUD insertions were performed by nurse practitioners, obstetrics and gynecology residents and attending physicians after standardized training on gel placement. After speculum insertion, the study syringe was attached to a sterile 14-gauge 2-in. catheter, and a 3 mL of active or placebo gel was extruded on to the anterior lip of the cervix. The catheter was then introduced into the cervical canal up to but not through the internal os, and the remaining gel in the syringe (3 mL) was introduced. After waiting 3 min to allow for the onset of action of the lidocaine gel [20], the tenaculum was placed. Subjects were asked to report their pain level with the tenaculum placement using the 0 to 100 VAS. The subject was asked, “On this scale where 0 is no pain and 100 is the worst pain ever, what was that like for you?” The VAS has been validated by various studies to be an effective way to measure acute pain intensity and has been used in past IUD insertion studies [7,22,23]. IUD insertion was then per- formed in the standard manner after sounding the uterus. Subjects were again asked to rate their pain with IUD insertion on the 0 to 100 VAS. We also measured the sub- ject's pain rating with speculum insertion in a similar manner to determine baseline pain tolerance. Other procedure 732 R.H. Allen et al. / Contraception 88 (2013) 730–736 characteristics collected during the IUD insertion were procedure time (from tenaculum placement to removal of inserter tube), insertion difficulty as rated by the clinician (easy, average and difficult), timing of IUD insertion (6 to 12 weeks postpartum, 2 to 4 weeks postabortion or interval — not related to pregnancy), uterine position, uterine size, type of IUD, clinician performing the insertion and any insertion complications. Lidocaine side effects were also queried after the procedure such as ringing in the ears and numbness or tingling around the mouth. Approximately 20 min post- insertion, we measured pain levels on the VAS, side effects such as nausea, vomiting and dizziness, and the acceptability of the pain experienced during the IUD insertion. The efficacy of blinding was measured by asking participants what regimen they thought they received. The primary outcome for this study was the IUD insertion pain score. Assuming an alpha of 0.05, 80% power and a standard deviation of 32 mm (based on a previous study in the clinic), we planned to recruit 72 women per arm to be able to detect a 15-mm mean difference between groups on the 0- to Women asses eligibili n=272 Eligible f participat n=181 Excluded n=91 Declined participation n=31 Randomi n=150 Lidocaine gel n=75 No IUD insertion n=1 Protocol violation n=2 Analyzed n=72 Fig. 1. Participan 100-mmVAS. Prior studies have shown a range for a clinically significant difference in acute pain on the VAS from 13 to 16 mm [24–26]. We aimed to detect a 15-mm difference because we considered this difference to be clinically significant and wanted to minimize a potential Type II error. Adding 5% to account for subject dropout, we planned to recruit a total of 150 women or 75 subjects per arm. The statistical software package Statistical Analysis System (SAS) version 9.2 (SAS Institute, Cary, NC, USA) was used for all data analyses. Categorical variables were compared by chi-square or Fisher's Exact Test. Continuous variables were compared by t test or Wilcoxon rank sum test. The association of lidocaine gel with pain on IUD insertion was examined by multiple linear regression. Variables were selected for inclusion if they were associated with pain on IUD insertion with pb.1 in the univariable analysis. Interactions between treatment group and predictors were evaluated by an overall F test, followed by testing the treatment effect within subgroups of the predictor by the Dunnett method. Categories were combined for nominal and sed for ty or ion zed Placebo gel n=75 No IUD insertion n=2 Analyzed n=73 t flowchart. Table 1 Sociodemographic characteristics of study participants by randomization group Variable Placebo gel Lidocaine gel p Total 73 (50.3) 72 (49.7) Age (years) Mean (SD) 25.2 (5.0) 26.2 (5.3) .2 Median (range) 24.0 (18.0–41.0) 25.0 (19.0–41.0) Race/Ethnicity Hispanic 23 (31.5) 23 (31.9) .7 Black 18 (24.7) 12 (16.7) White 20 (27.4) 22 (30.6) Other 12 (16.4) 15 (20.8) Insurance Medicaid 63 (86.3) 61 (84.7) .9 Private insurance/Health maintenance organization 8 (11.0) 8 (11.1) Self-pay/Other 2 (2.7) 3 (4.2) Body mass index Mean (SD) 31.6 (8.1) 29.9 (7.8) .2 Gravida Median (range) 2.0 (0.0–7.0) 2.0 (0.0–8.0) .08 Parity Median (range) 1.0 (0.0–5.0) 2.0 (0.0–7.0) .2 Delivery history Nulliparous 5 (6.8) 3 (4.2) .3 Cesarean only 17 (23.3) 11 (15.3) Vaginal with or without cesarean 51 (69.9) 58 (80.6) History of cervical conization No 70 (95.9) 69 (95.8) 1.0 Yes 3 (4.1) 3 (4.2) Currently breastfeeding No 50 (68.5) 49 (68.1) 1.0 Yes 23 (31.5) 23 (31.9) Timing of IUD insertion Postpartum 46 (63.0) 43 (59.7) .7 Postabortion 2 (2.7) 4 (5.6) Interval (gynecologic visit) 25 (34.2) 25 (34.7) Uterine position Midposition 16 (21.9) 11 (15.3) .5 Anteverted 39 (53.4) 45 (62.5) Retroverted 18 (24.7) 16 (22.2) Type of IUD Cu-T380A 10 (13.7) 10 (13.9) 1.0 Levonorgestrel 63 (86.3) 62 (86.1) State-anxiety T-score Mean (SD) 49.0 (9.3) 48.2 (10.1) .6 Trait-anxiety T-score Mean (SD) 50.5 (12.5) 50.0 (11.5) .8 How do you expect your pain to be (0 to 100)? Mean (SD) 35.1 (19.8) 41.8 (23.3) .06 Median (range) 36.0 (0.0–79.0) 47.0 (0.0–96.0) How much pain would you consider acceptable (0 to 100)? Mean (SD) 49.8 (27.7) 48.8 (26.5) .8 Median (range) 50.0 (0.0–100.0) 48.5 (0.0–100.0) How would you rate your pain tolerance? Low 10 (13.7) 11 (15.3) .6 Moderate 34 (46.6) 27 (37.5) High 29 (39.7) 34 (47.2) On average, during the last 3 months, have your periods been associated with any pain? None–Slight pain 35 (47.9) 45 (62.5) .1 Moderate pain 24 (32.9) 20 (27.8) Severe–Very severe pain 14 (19.2) 7 (9.7) Data are N (column %) unless otherwise noted. Missing data no more than 2.1%. Percentages may not sum to 100 due to rounding. 733R.H. Allen et al. / Contraception 88 (2013) 730–736 able 3 ther procedure-related variables and complications by randomization group ariable Placebo Lidocaine p otal 73 (50.3) 72 (49.7) 734 R.H. Allen et al. / Contraception 88 (2013) 730–736 ordinal independent variables when necessary to avoid small numbers. Residual plots were inspected for influential points and heteroskedasticity. All p values presented were two tailed, with pb.05 considered statistically significant. otal procedure time(sec) Median (range) 99.5 (52.0–1719.0) 111.0 (64.0–569.0) .6 sertion difficulty Easy 47 (66.2) 47 (67.1) .9 Average 22 (31.0) 20 (28.6) Difficult 2 (2.8) 3 (4.3) cute complications None 72 (98.6) 71 (98.6) 1.0 Vasovagal reaction 0 (0.0) 1 (1.4) Other 1 (1.4) 0 (0.0) elayed complications at 12 weeks None 70 (97.2) 70 (97.2) 1.0 Uterine infection 1 (1.4) 0 (0.0) Partial IUD expulsion 1 (1.4) 1 (1.4) Complete IUD expulsion 0 (0.0) 1 (1.4) t its worst, how nauseous you have felt since the procedure? No nausea 63 (86.3) 67 (94.4) .3 Mild nausea 5 (6.8) 3 (4.2) Moderate nausea 2 (2.7) 1 (1.4) Severe nausea 3 (4.1) 0 (0.0) t its worst, how dizzy have you felt since you had the procedure? Not dizzy 61 (83.6) 65 (91.5) .4 Mildly dizzy 7 (9.6) 4 (5.6) Moderately dizzy 3 (4.1) 2 (2.8) Severely dizzy 2 (2.7) 0 (0.0) verall, how acceptable would you rate the amount of pain you had during the IUD insertion today? Completely acceptable 36 (49.3) 31 (44.3) .2 Mostly acceptable 19 (26.0) 21 (30.0) Somewhat acceptable 11 (15.1) 17 (24.3) Mostly unacceptable 6 (8.2) 1 (1.4) Completely unacceptable 1 (1.4) 0 (0.0) ata are N (column %) unless otherwise noted. issing data no greater than 2.8%. ercentages may not sum to 100 due to rounding. 3. Results A total of 272 women seeking IUD insertion were screened for study eligibility. Of these, 91 were ineligible, 31 declined to participate and 150 were enrolled (Fig. 1). Of those ineligible, the most common reason was prior IUD use (59%), followed by analgesic use in the past 12 h (21%), and under age 18 (13%). Five participants were dropped from the study for protocol violations leaving 145 for analysis: 3 who did not have an IUD insertion, 1 who was later determined to be ineligible because she had a prior IUD and 1 where only 2 mL of gel was used inadvertently. No participants withdrew from the study. There were 37 different providers who participated in the study. Grouping providers by experience, 63% were attending physicians or nurse practitioners, and the remainder were resident physicians (PGY2 or above). The two groups were similar in age, race/ethnicity, health insurance and parity as well as procedure characteristics such as timing of IUD insertion and type of IUD (Table 1). When asked what level of pain was expected for the IUD insertion, subjects in the lidocaine group reported a mean pain score of 41.8 (median: 47), and the placebo group reported a mean of 35.1 (median: 36) on a scale from 0 to 100 (p=.06). Baseline anxiety, pain tolerance and history of dysmenorrhea were similar between the two groups as well (Table 1). The two groups had similar baseline pain scores with speculum insertion (Table 2). The lidocaine group reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p= Table 2 Pain scores by randomization group Variable Placebo Lidocaine p Total 73 (50.3) 72 (49.7) Pain with speculum insertion Mean (SD) 21.5 (23.7) 23.5 (23.8) .6 Median (range) 16.0 (0.0–100.0) 12.5 (0.0–71.0) Interquartile range 2.0–32.0 3.5–39.5 Pain with tenaculum placement Mean (SD) 41.6 (31.5) 37.5 (26.2) .4 Median (range) 37.0 (0.0–100.0) 39.0 (0.0–89.0) Interquartile range 12.0–67.0 12.0–57.0 Pain during IUD insertion Mean (SD) 36.7 (30.0) 35.2 (27.7) .8 Median (range) 36.0 (0.0–100.0) 34.0 (0.0–93.0) Interquartile range 7.0–58.0 11.0–58.0 Pain 20 min postinsertion Mean (SD) 21.4 (25.2) 20.6 (24.0) .8 Median (range) 10.5 (0.0–100.0) 10.0 (0.0–83.0) Interquartile range 1.0–34.5 2.0–36.0 Missing data for postinsertion no greater than 2.1%. T O V T T In A D A A O D M P .4). Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median: 36) in the placebo group (p=.8) (Table 2). Controlling for expected pain and baseline pain with speculum insertion did not change the results. When the analysis was repeated among only women who were nulli- parous or only had cesarean sections without labor (functionally nulliparous), there was still no difference in pain scores between the lidocaine and placebo groups (data not shown). There was no difference between the groups in procedure difficulty as rated by the provider (Table 3). Only one woman, who had a history of cesarean delivery only, required cervical dilation for IUD placement. There were two complications, one vasovagal reaction and 1 IUD that was pulled out accidentally with scissors and had to be replaced. No participants reported any systemic lidocaine side effects. We also performed a multiple linear regression analysis to identify predictors of pain with IUD insertion. After con- trolling for randomization group, baseline speculum pain score, delivery history, breastfeeding, insertion timing, 735R.H. Allen et al. / Contraception 88 (2013) 730–736 uterine position (mid, anteverted or retroverted) and history of dysmenorrhea (severe–very severe pain during menses), we found that nulliparity, interval IUD insertion and history of dysmenorrhea were predictive of pain during IUD insertion (data not shown). Increased pain was associated with nulliparity [57.7, 95% confidence interval (CI): 38.7– 76.8], interval insertion (53.2, 95% CI: 43.3–63.1) and dysmenorrhea (51.7, 95% CI: 38.0–65.3). A statistically significant interaction between randomization group and dysmenorrhea was observed (p=.01). Among patients with severe to very severe pain during menses, lidocaine treatment was associated with a 31.8 point (95% CI: 0.9– 62.8, p=.04) decrease in pain on the VAS compared to placebo. There was no interaction between randomization group and delivery history (nulliparity, cesarean section [C/S] only or vaginal with or without C/S) (p=.5). Postprocedure, there was no difference between the groups in pain, nausea or dizziness (Table 3). The groups were similar in terms of satisfaction with procedure pain. Delayed complications were assessed for an additional 3 months following the IUD insertion and were no different between the two groups (Table 3). Finally, to assess the efficacy of blind- ing, we asked participants to guess their treatment arm after the IUD insertion. A chi-square test to assess a success of blinding demonstrated no association between the partici- pant's guess and actual treatment assignment (p=.8). 4. Discussion We found that women who received 3 mL of 2% lidocaine gel to the anterior lip of the cervix and 3 mL to the internal os did not have reduced pain with tenaculum placement or IUD insertion compared to placebo gel. This was true even among women who were nulliparous or only had previous cesarean sections without labor. These findings and our pain scores are consistent with previous trials [10,19]. In the trial byMaguire et al., with a greater proportion of nulliparous women than our study, mean pain scores with IUD insertion were 50.9 in the placebo arm and 51.0 in the 2% lidocaine gel arm. McNicholas et al. reported median pain scores with placebo gel of six in nulliparous women and five in parous women compared with six in nulliparous women and four in parous women with the 2% lidocaine gel. In our study, we found that lidocaine may have a beneficial effect in the subgroup of women with a history of severe to very severe dysmenorrhea; however, additional studies powered to evaluate this association are needed. Our study confirmed that nulliparity, interval insertion and history of dysmenorrhea were predictors of pain with IUD insertion after adjusting for randomization group, baseline speculum pain score, breastfeeding and uterine position. This is similar to Maguire et al.'s analysis of predictors of pain except that they found increased pain with the copper IUD compared to the levonorgestrel intrauterine system, which we did not. This study has several strengths. Since the initial pro- mising study on 2% lidocaine gel for IUD insertion in 1996 [17], this study joins two other randomized controlled trials in confirming lack of efficacy[10,19]. We utilized 6 mL of gel as did the original study by Oloto et al. and waited 3 min to allow for onset of action. We also used a larger amount of gel at the tenaculum site compared to other studies (3 mL vs. 1 mL). In addition, we had an adequate sample size to demonstrate a statistically significant difference. Furthermore, we limited enrollment to women who had no prior experience with IUD insertions and did not use analgesics other than the study intervention. Limitations to our study include the low numbers of nulli- parous women who participated; there were 8 nulliparous women (5.5%) compared to 137 multiparous women (94.5%). This is a reflection of the population of women who presented for care at the recruitment site. Nevertheless, another randomized controlled trial of 2% lidocaine gel with adequate numbers of nulliparous women reported no difference in IUD insertion pain scores among that population [18]. In addition, our study was conducted in a teaching hospital, and 37 different providers participated. The mean number of IUD insertions per study provider was 3.9 (SD: 5.0). Therefore, we were unable to ascertain provider effect on IUD insertion pain. However, our results can be generalized to providers with a variety of skill level, and the subjects were equally randomized to residents and faculty-level providers (nurse practitioners and attending physicians). Furthermore, when analyzed, there was no difference in pain score by experience level (resident vs. faculty) among the two groups. Promoting the use of IUDs is an important step towards reducing the unintended pregnancy rate [3,24]. IUDs have high satisfaction and continuation rates, despite the discom- fort women may experience at the time of insertion [2]. While more research is needed into strategies to reduce pain during IUD insertion, the more women are counseled on what to expect during IUD insertion, they may be more likely to opt for IUDs. Possible interventions to research in the future include a 20-mL 1% lidocaine paracervical or intracervical block and intrauterine lidocaine infusion. 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