ライフサイエンスコーパス: non-inferiority

1 io [HR] 1.00, 95% CI 0.68-1.49, p=0.0019 for non-inferiority).

2 , 95% CI 0.85-1.14; stratified p=0.00092 for non-inferiority).

3 ticosteroids with a 37% acceptable margin of non-inferiority.

4 % CI -2.8 to 4.5]), meeting the criteria for non-inferiority.

5 6% was within the prespecified threshold for non-inferiority.

6 but a dose of 0.1 mg/kg was inconclusive for non-inferiority.

7 CI of -0.5 days predetermined to demonstrate non-inferiority.

8 tudy was not powered to prove equivalence or non-inferiority.

9 ne] 0.08%, 95% CI -0.05 to 0.21), confirming non-inferiority.

10 2.0%, 95.001% CI -5.9 to 1.8), demonstrating non-inferiority.

11 4.3), meeting the prespecified criteria for non-inferiority.

12 0.5), meeting the prespecified criterion for non-inferiority.

13 CI -3.6 to 7.2]; p=0.47), which demonstrates non-inferiority.

14 ifference 25% [6-43], OR 2.78 [1.25-6.22]; p(non-inferiority)=0.0001, p(superiority)=0.02).

15 nce -21% [-39 to -3], OR 0.34 [0.14-0.81]; p(non-inferiority)=0.0001, p(superiority)=0.02).

16 Non-inferiority (10% margin) was assessed by comparing t

17 within 30 days, which was used to establish non-inferiority (15% margin) of ridinilazole versus vanc

18 er mL) cumulative through week 48; we tested non-inferiority (4% margin) of the study regimen versus

19 e primary evaluation of immunogenicity was a non-inferiority analysis.

20 in the omeprazole group for the per protocol non-inferiority analysis.

21 We used a 10% margin for non-inferiority and equivalence analyses.

22 (adjusted difference 7.1%, 95% CI 0.9-13.2), non-inferiority and on pre-specified secondary analysis

23 in August, 2013, and a post-hoc analysis of non-inferiority and safety in March, 2016, of the patien

24 ents in the plasma group, demonstrating both non-inferiority and superiority of 4F-PCC over plasma (d

25 ents in the plasma group, demonstrating both non-inferiority and superiority of 4F-PCC over plasma (d

26 (95% CI 1.11-1.96), exceeding the limit for non-inferiority, and CABG was significantly better than

27 specifying the requirements for superiority, non-inferiority, and equivalence trials, we did a system

28 ratio [HR] 1.9, 95% CI 0.6-6.4; p=0.0025 for non-inferiority) at day 45.

29 Randomised trials have shown non-inferiority between BVS and metallic drug-eluting st

30 Non-inferiority between groups was shown if the lower bo

31 Non-inferiority can be claimed for both reduced-dose and

32 esent controlled, randomized, double-masked, non-inferiority clinical trial is to evaluate the effect

33 nal intradermal doses of IPV did not achieve non-inferiority compared with full dose.

34 The primary non-inferiority comparison combined these data from two

35 The primary endpoint was a non-inferiority comparison of a device-oriented composit

36 Non-inferiority comparisons could not be done for this o

37 (HR 0.84 [90% CI 0.68-1.03], pNI=0.0018) but non-inferiority could not be claimed for 57 Gy compared

38 1%, 95% CI 0.08-0.33) not meeting predefined non-inferiority criteria (upper limit of CI <0.25%).

39 The predefined non-inferiority criteria were -12% absolute and -20% rel

40 Treatment with lacosamide met the predefined non-inferiority criteria when compared with carbamazepin

41 Treatment with lacosamide met the predefined non-inferiority criteria when compared with carbamazepin

42 ease inhibitor plus raltegravir did not meet non-inferiority criteria.

43 erior to surgery according to our predefined non-inferiority criterion.

44 with the standard five-dose regimen using a non-inferiority design (with non-inferiority margins of

45 rials in diabetes, but most trials opted for non-inferiority designs aiming primarily to show absence

46 afety analysis and mITT and per protocol for non-inferiority effectiveness analysis) used a regressio

47 The primary non-inferiority endpoint was the frequency and timing of

48 The primary non-inferiority endpoints were total clinical failure an

49 randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial.

50 r) related to HPV 31, 33, 45, 52, and 58 and non-inferiority (excluding a decrease of 1.5 times) of a

51 We did an open-label, non-inferiority, five-arm, randomised controlled trial i

52 eedle-free jet injector met the criteria for non-inferiority for all six coprimary endpoints.

53 We used a 10% margin to establish non-inferiority for bOPV groups versus mOPV1 groups in s

54 If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these f

55 can be sufficient to ascertain immunological non-inferiority for licensure for alternate dosing sched

56 up met the seroconversion rate criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (u

57 p met the geometric mean titre criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (u

58 We did a randomised controlled, non-inferiority, four-period crossover trial at three si

59 88 the null hypothesis for the corresponding non-inferiority hypothesis was not rejected.

60 ration but the seroconversion rates achieved non-inferiority in both cases (rubella, -4.5% [95% CI -9

61 drug) and used a margin of 0.3% to establish non-inferiority in HbA1c reduction.

62 The primary endpoint of the trial was non-inferiority in mean differences between groups in th

63 Indacaterol did not show non-inferiority in terms of annualised exacerbation rate

64 change in HbA(1c) from baseline to 26 weeks (non-inferiority limit of 0.4%) by ANOVA in an intent-to-

65 change in HbA(1c) from baseline to week 52 (non-inferiority limit of 0.4%) by ANOVA in the full anal

66 ome was BCVA at 2 years, with a prespecified non-inferiority limit of 3.5 letters.

67 o evaluate, in a hierarchical fashion, first non-inferiority (lower limit 95% CI greater than -10% fo

68 odds ratio [OR] 4.87 [95% CI 2.14-11.10]; p(non-inferiority)<0.0001, p(superiority)=0.0001).

69 e upper bound of the 95% CI exceeded the 15% non-inferiority margin (difference 9.1%, 95% CI -5.6 to

70 ence limit for difference 10.2% vs specified non-inferiority margin 10%).

71 y -2.6% [95% credible interval -5.5 to 0.1], non-inferiority margin 3.85%, n=2208).

72 t of the 97.5% CI was above the prespecified non-inferiority margin of -0.055 L, suggesting that inda

73 ), with a difference within the prespecified non-inferiority margin of -0.19 (95% CI -0.51 to 0.13; p

74 a at 48-72 h compared with baseline), with a non-inferiority margin of -10%.

75 We used a non-inferiority margin of -12%.

76 tion snapshot algorithm, with a prespecified non-inferiority margin of -12%.

77 ion snapshot algorithm), with a prespecified non-inferiority margin of -12%.

78 using a one-sided asymptotic test, against a non-inferiority margin of 0.14 mm.

79 ge in HbA1c from baseline to week 52, with a non-inferiority margin of 0.3% for the comparison of eac

80 y change in HbA1c from baseline to 32 weeks (non-inferiority margin of 0.4%).

81 up adjusted for age and duration of illness (non-inferiority margin of 0.75 kg/m(2)).

82 gh serum concentration at cycle five, with a non-inferiority margin of 0.8 for the adjusted geometric

83 ity of OCT guidance to IVUS guidance (with a non-inferiority margin of 1.0 mm(2)), superiority of OCT

84 b was not 67.5% or less with a corresponding non-inferiority margin of 1.388 for the hazard ratio (HR

85 pper limit of this 95% CI did not exceed the non-inferiority margin of 1.5 that was prespecified for

86 We did a per-protocol analysis with a non-inferiority margin of 10% for poliovirus seroprevale

87 nsitive at trial entry (assessed at 3 years; non-inferiority margin of 10%).

88 ation snapshot algorithm with a prespecified non-inferiority margin of 10%.

89 intention-to-treat (MITT) population, with a non-inferiority margin of 10%.

90 e 95% CI 13.2, greater than the prespecified non-inferiority margin of 10%]).

91 f the 95% CI 9.2, less than the prespecified non-inferiority margin of 10%]).

92 week 48 based on a snapshot algorithm with a non-inferiority margin of 12% (assessed by modified inte

93 tion (FDA) snapshot algorithm (pre-specified non-inferiority margin of 12%) and pre-specified renal a

94 inistration snapshot algorithm (prespecified non-inferiority margin of 12%).

95 We established a non-inferiority margin of 12%.

96 upper limit of the 95% CI was less than the non-inferiority margin of 15%.

97 st on the hazard ratio was 0.00-5.27, with a non-inferiority margin of 2.

98 e group of 0.75 mg primaquine per kg, with a non-inferiority margin of 2.5 days.

99 in the conserved breast, with a prespecified non-inferiority margin of 2.5% at 5 years; prespecified

100 a 3% annual thromboembolism incidence and a non-inferiority margin of 2.5%.

101 lure and total female condom failure, with a non-inferiority margin of 3%.

102 We used a non-inferiority margin of 4.5% (absolute difference betw

103 ion snapshot algorithm), with a prespecified non-inferiority margin of 8%.

104 ion snapshot algorithm), with a prespecified non-inferiority margin of 8%.

105 We used a prespecified non-inferiority margin of a relative risk (RR) of 0.87.

106 from a general linear mixed model, with the non-inferiority margin set at 15 cm/s.

107 The non-inferiority margin was -12%.

108 The non-inferiority margin was 1.9 PHQ-9 points.

109 The non-inferiority margin was 10%, assessed in the per-prot

110 The pre-specified non-inferiority margin was 10%.

111 The non-inferiority margin was 12%.

112 The non-inferiority margin was 15%.

113 The non-inferiority margin was 25% for eliglustat relative t

114 The non-inferiority margin was a hazard ratio (HR) of 1.5 ca

115 ure-confirmed recurrent melioidosis, and the non-inferiority margin was a hazard ratio (HR) of 1.7.

116 The non-inferiority margin was prespecified as -5 Early Trea

117 The non-inferiority margin was specified as 0.6 DAS28-ESR un

118 ome measure result includes the prespecified non-inferiority margin, the combination of the small dif

119 ter the first dose of study drug, with a 10% non-inferiority margin.

120 ntion-to-treat [ITT] population) using a 10% non-inferiority margin.

121 0 day patient and graft survival, with a 10% non-inferiority margin.

122 HbA1c) from baseline to week 26, with a 0.4% non-inferiority margin.

123 5% CI -3.0 to 8.2), meeting the prespecified non-inferiority margin.

124 A] snapshot algorithm) at week 48 with a 12% non-inferiority margin.

125 ehaviour by counselling strategy with a 6.5% non-inferiority margin.

126 o the US FDA snapshot algorithm), with a 12% non-inferiority margin.

127 h lay on the positive side of the predefined non-inferiority margin.

128 lapse (80% power to exclude a 2.5% increase [non-inferiority margin] at 5 years for each experimental

129 The primary outcome was non-inferiority (margin 0.4%) of dulaglutide compared wi

130 We did non-inferiority (margin 7.5%) and superiority analyses i

131 regimen using a non-inferiority design (with non-inferiority margins of 10%).

132 In this phase 2, non-inferiority, observer-blinded, randomised, controlle

133 The upper CI was greater than the margin of non-inferiority of 1.08; therefore, we could not reject

134 We aimed to assess pharmacokinetic non-inferiority of 3 week cycles of fixed-dose subcutane

135 The primary endpoint was non-inferiority of 5-year axillary recurrence, considere

136 The FLUID study investigates the non-inferiority of a Treat and Extend (T&E) protocol of

137 The non-inferiority of anastrozole was established (upper 95

138 The co-primary endpoint is the non-inferiority of angiographic late luminal loss.

139 We aimed to assess non-inferiority of anticoagulation stabilisation with a

140 ETATION: The per-protocol analysis suggested non-inferiority of AQ-13 to artemether plus lumefantrine

141 AQ-13 group, did not meet the criterion for non-inferiority of AQ-13, although there were no AQ-13 t

142 We aimed to establish non-inferiority of behavioural activation therapy for ma

143 n-free survival with the objective to assess non-inferiority of bendamustine and rituximab to the sta

144 .002% CI -4.8 to 3.6; p=0.78), demonstrating non-inferiority of bictegravir, emtricitabine, and tenof

145 Non-inferiority of ceftaroline fosamil was defined as a

146 If non-inferiority of cisplatin plus gemcitabine compared w

147 ome, KT width at 6 months, did not establish non-inferiority of CM compared to FGG (P = 0.9992), with

148 The primary outcome was non-inferiority of degludec to glargine measured by chan

149 The primary outcome was non-inferiority of degludec to glargine, assessed as a r

150 The primary endpoint was non-inferiority of event-free survival at 2 years, analy

151 The primary outcome was non-inferiority of IDeg 3TW compared with IGlar OD, as a

152 nt, and the main objective was to assess the non-inferiority of IDegLira to insulin degludec (with an

153 vaccine (PCV10), which was licensed based on non-inferiority of immunological correlates of protectio

154 tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a

155 We tested non-inferiority of OCT guidance to IVUS guidance (with a

156 INTERPRETATION: We showed non-inferiority of partial-breast and reduced-dose radio

157 Non-inferiority of PCI to CABG required the lower end of

158 Non-inferiority of response was shown if the one-sided 9

159 90% CI 3.1-39.1, p=0.0004), establishing the non-inferiority of ridinilazole and also showing statist

160 The primary outcome was non-inferiority of stepwise addition of bolus insulin ve

161 We aimed to show the pharmacokinetic non-inferiority of subcutaneous rituximab to intravenous

162 udy, we aimed to confirm the pharmacokinetic non-inferiority of subcutaneous rituximab, and investiga

163 roup (ratio 1.62, 90% CI 1.36-1.94), showing non-inferiority of subcutaneous rituximab.

164 We assessed the non-inferiority of such a switch compared with continuat

165 ence -0.3%, 95.001% CI -4.2 to 3.7), showing non-inferiority of tenofovir alafenamide to tenofovir di

166 ifference 1.3%, 95% CI -2.5 to 5.1), showing non-inferiority of tenofovir alafenamide to tenofovir di

167 5%, 95.002% CI -7.9 to 1.0, p=0.12), showing non-inferiority of the bictegravir regimen to the dolute

168 Co-primary outcomes were non-inferiority of the bOPV-containing schedules compare

169 The EXAMINE trial showed non-inferiority of the DPP-4 inhibitor alogliptin to pla

170 The primary efficacy endpoint was the non-inferiority of the mean duration of gametocyte carri

171 A margin of 4.0% was defined for non-inferiority of the MiStent group compared with the X

172 rafenib, results did not show superiority or non-inferiority of the new therapies.

173 We tested non-inferiority of the primary efficacy endpoint of all-

174 This study was not powered to detect non-inferiority of the shorter protocol versus the stand

175 eceiving the five-dose i.m. regimen, showing non-inferiority of the simplified three-dose regimen to

176 ent treatment-comparison design to establish non-inferiority of the test (CM) versus control (FGG) th

177 99% reduction in parasitemia at 24 h; hence, non-inferiority of this regimen to the five-dose control

178 e aim of this clinical trial was to show the non-inferiority of three IPV-Al vaccines to standard IPV

179 ; treatment difference was 0.21% (0.08-0.34; non-inferiority p value=0.0846).

180 Non-inferiority (p=8.82 x 10(-16)) and post-hoc superior

181 We did a randomised, open-label, non-inferiority, parallel-group, multicentre, multinatio

182 active-controlled, multicentre, randomised, non-inferiority phase 3 study was done in 99 UK hospital

183 The CHHiP trial is a randomised, non-inferiority phase 3 trial done in 71 centres, of whi

184 ticentre, active-controlled, parallel-group, non-inferiority phase 3b study done in 86 hospital and u

185 his open-label, masked endpoint, randomised, non-inferiority phase 3b trial, we recruited patients ag

186 ent for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK

187 this international, multicentre, open-label, non-inferiority, phase 3, randomised SIOP WT 2001 trial,

188 The non-inferiority primary effectiveness outcome was the pr

189 did a multicentre, prospective, open-label, non-inferiority randomised clinical trial (Sita-Hospital

190 In a multicentre, 2x2 factorial, non-inferiority randomised trial, we enrolled adults age

191 a single centre, double-blind, prospective, non-inferiority, randomised controlled clinical trial.

192 id a multicentre, parallel-group, pragmatic, non-inferiority, randomised controlled trial at 12 centr

193 ear, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients

194 For this multi-centre, double-blind, non-inferiority, randomised placebo-controlled trial, we

195 In this phase 3, non-inferiority, randomised, controlled trial (CHORUS) u

196 30 September 2013, we conducted an unblinded non-inferiority randomized controlled trial of CTX proph

197 y endpoint was overall survival assessed for non-inferiority (retention of >/= 50% of the cetuximab t

198 ial (ETP) from randomisation to day 42, with non-inferiority set at less than 20% difference from war

199 I-mono group: difference 1.4% (-0.4 to 3.4); non-inferiority shown.

200 (at patient level, blocks of 4), controlled non-inferiority study among children aged 2-59 months pr

201 A5273 was a randomised, open-label, phase 3, non-inferiority study at 15 AIDS Clinical Trials Group (

202 undertook this 32-week, open-label, phase 3 non-inferiority study at 162 sites in eight countries: U

203 phase 1b, open-label, randomised controlled non-inferiority study at 68 centres in 19 countries in E

204 a prospective randomised, unblinded, phase 3 non-inferiority study comparing radiotherapy given as 4

205 This phase 3, non-inferiority study enrolled treatment-naive patients

206 s ongoing randomised, double-blind, phase 3, non-inferiority study in 105 centres in 17 countries, pa

207 We did this ongoing double-blind, non-inferiority study in 161 outpatient centres in 19 co

208 NGO was a multicentre, open-label, phase 3b, non-inferiority study of HIV-1-infected treatment-naive

209 In this multicentre, open-label, phase 3b, non-inferiority study, HIV-1-infected antiretroviral the

210 ised, double-blind, parallel-group, phase 3, non-inferiority study, we enrolled participants aged 18

211 ronic hepatitis B virus (HBV) infection in a non-inferiority study.

212 randomised, double-blind, active-controlled, non-inferiority study.

213 ronic hepatitis B virus (HBV) infection in a non-inferiority study.

214 The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0.00-5.27,

215 The planned non-inferiority test was underpowered because of the low

216 points [95% CI -0.14 to 0.11]; p<0.0001 for non-inferiority testing) and 188 (40%) and 67 (43%) part

217 To establish non-inferiority, the upper bound of a one-sided 90% CI f

218 INTERPRETATION: The trial met the non-inferiority threshold for the primary endpoint, beca

219 The trial met the non-inferiority threshold for the primary endpoint, beca

220 ETP for rivaroxaban did not reach the non-inferiority threshold, but as there was no increase

221 set was first tested and then, if positive, non-inferiority to entacapone was tested in the per-prot

222 , but the 5 mg twice daily dose did not show non-inferiority to etanercept 50 mg twice weekly.

223 In this phase 2b, single-blind, non-inferiority trial (CLARITY), adults (aged >/=18 year

224 untries into a randomised (1:1), open-label, non-inferiority trial (NEAT001/ANRS143) assessing the ef

225 m in a multinational, phase 3, double-blind, non-inferiority trial (REPROVE).

226 this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIM

227 is 52 week, randomised, open-label, phase 3, non-inferiority trial at 105 study sites in 15 countries

228 double-dummy, randomised, active-controlled, non-inferiority trial at 114 centres in North America, L

229 re, active-controlled, randomised controlled non-inferiority trial at 122 outpatient centres in nine

230 ed, double-blind, active-controlled, phase 3 non-inferiority trial at 157 centres in 19 countries bet

231 We did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centre

232 pective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in

233 We did a phase 4, randomised, non-inferiority trial at three periurban government clin

234 le-blind, double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 Se

235 icentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon(R) (4 x 10 mL/da

236 allel-group, multinational, treat-to-target, non-inferiority trial done at 150 sites across seven cou

237 ulticentre, phase 3, randomised, open-label, non-inferiority trial done at 26 paediatric hospitals an

238 andomised, controlled, four-arm, open-label, non-inferiority trial done at five primary health-care c

239 H-2 was a randomised, double-blind, phase 3, non-inferiority trial done between Sept 28, 2011, and Ja

240 as a randomised, double-blind, double-dummy, non-inferiority trial done in 209 centres in 25 countrie

241 ulticentre, randomised, controlled, phase 3, non-inferiority trial done in 30 radiotherapy centres in

242 This open-label, randomised controlled, non-inferiority trial enrolled patients with active, ser

243 lticentre, randomised, open-label, phase 3b, non-inferiority trial enrolling adults (>/=18 years) wit

244 was a randomised, double-blind, event driven non-inferiority trial in 8292 patients comparing edoxaba

245 phase 3, randomised, controlled, open-label, non-inferiority trial in antiretroviral-therapy-naive ad

246 was a randomised, double-blind, event-driven non-inferiority trial in patients from centres in 37 cou

247 ive adults into this randomised, open-label, non-inferiority trial in treatment-naive adults in 15 Eu

248 CHHiP is a randomised, phase 3, non-inferiority trial that recruited men with localised

249 We did a randomised, controlled, open-label, non-inferiority trial with healthy, full-term (>2.5 kg b

250 In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradi

251 , double-dummy, placebo-controlled, 12-week, non-inferiority trial, adult patients with chronic stabl

252 ndomised, controlled, open-label, phase 2/3, non-inferiority trial, done in two UK hospitals, include

253 andomised, double-blind, placebo-controlled, non-inferiority trial, HIV-1-infected adults were enroll

254 uble-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-1-infected adults were screen

255 uble-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-infected adults were screened

256 In this phase 3, randomised, double-blind, non-inferiority trial, patients from 185 epilepsy or gen

257 In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary

258 l-group, randomised, controlled, open-label, non-inferiority trial, we enrolled adults (>/=18 years o

259 se 3, randomised, multinational, open-label, non-inferiority trial, we enrolled adults (aged >/=18 ye

260 or this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged

261 In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hos

262 In this randomised, parallel-group, non-inferiority trial, we enrolled patients from 18 site

263 In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years

264 ctively controlled, multicentre, open-label, non-inferiority trial, we recruited HIV-1-infected adult

265 In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged >/=58

266 We did a randomised, non-inferiority trial.

267 TARGIT-A was a randomised, non-inferiority trial.

268 eek, randomised, open-label, parallel group, non-inferiority trials IDeg was injected Monday, Wednesd

269 lbiglutide versus liraglutide, with a 95% CI non-inferiority upper margin of 0.3%.

270 The margin used to establish non-inferiority was 1.2.

271 failure; the critical hazard ratio (HR) for non-inferiority was 1.208.

272 ients clinically cured of -10% or higher; if non-inferiority was achieved, superiority was to be conc

273 then superiority (lower limit 95% CI >0%) if non-inferiority was achieved.

274 Non-inferiority was concluded if the lower bound of the

275 Non-inferiority was concluded if the lower limit of the

276 Non-inferiority was concluded if the lower two-sided 90%

277 Non-inferiority was considered established if the propor

278 Non-inferiority was declared for tofacitinib and methotr

279 days of therapy (point-of-care measurements; non-inferiority was deemed a difference <1 mmol/L).

280 cified non-inferiority with a 12% margin; if non-inferiority was established, superiority was tested

281 The criterion for non-inferiority was met (p=0.01).

282 Non-inferiority was not confirmed in either trial (estim

283 Regarding differences in means, non-inferiority was observed after 1 year (difference in

284 At the first scheduled interim analysis, non-inferiority was shown and the sponsor terminated the

285 Non-inferiority was shown between groups and no signific

286 Non-inferiority was shown for all condom failure events

287 gin] at 5 years for each experimental group; non-inferiority was shown if the upper limit of the two-

288 If non-inferiority was shown, we assessed superiority on th

289 und of the 95% CI (5.7%) did not exceed 10%, non-inferiority was shown.

290 For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic

291 Non-inferiority was thus shown for the bOPV-containing s

292 The criteria for non-inferiority were met.

293 of study drug; the study was powered to show non-inferiority with a 10% efficacy margin of tenofovir

294 We prespecified non-inferiority with a 12% margin; if non-inferiority wa

295 es per mL at week 144, for which we assessed non-inferiority with a one-sided alpha of 0.025, and sup

296 ndomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial, adult Asi

297 The secondary outcomes were non-inferiority (within 10% levels) at age 18 weeks for

298 At age 18 weeks, non-inferiority (within 10% levels) of the 2+1 group was

299 The primary outcome was non-inferiority (within a 20% margin) between groups in

300 Non-inferiority would be declared if the proportion of c