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DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment.
BackgroundThe commercial formulation of sumatriptan nasal spray is an effective option for migraine patients requiring or preferring a non-oral route of drug administration, but its utility is limited by poor absorption and tolerability issues. DFN-02, a new formulation of sumatriptan 10 mg nasal spray, is co-formulated with a permeation enhancer that gives it pharmacokinetics comparable to subcutaneous sumatriptan. As reported previously, DFN-02 was significantly better than placebo on multiple efficacy endpoints at 2 h postdose, including pain freedom, absence of the most bothersome symptom, and pain relief, and its safety and tolerability profiles were excellent.ObjectiveThe objective of this study was to assess the efficacy of acute treatment of migraine with DFN-02, including its effect on migraine-related functional disability and patient satisfaction with treatment.MethodsThis was a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of DFN-02 in adults with episodic migraine. Functional disability and subject satisfaction with treatment were prespecified endpoints, assessed in real-time by subjects, using an electronic diary.ResultsIn total, 107 subjects were randomized. DFN-02 was significantly superior to placebo for the reduction in functional disability score from predose level at 2 h after treatment (- 1.2 vs. - 0.6, p < 0.001). Subjects treated with DFN-02 were also more likely to be satisfied or very satisfied than subjects treated with placebo at 2 h postdose (70.0% vs. 44.2%, p = 0.027). Using the Patient Perception of Migraine Questionnaire-Revised at 24 h postdose, DFN-02 mean scores were significantly superior to placebo for the subscales of efficacy (65.2 vs. 42.5, p = 0.016) and function (68.9 vs. 42.1, p = 0.001), and for total score (71.0 vs. 56.6, p = 0.016); global medication effectiveness (p = 0.027); and overall satisfaction (p = 0.019). Placebo was significantly better than DFN-02 on the tolerability subscale (94.8 vs. 88.5, p = 0.026). At 24 h postdose, subjects reported significantly higher satisfaction with DFN-02 compared with satisfaction reported pre-randomization regarding their usual migraine medication (p = 0.012).ConclusionDFN-02 was superior to placebo for the relief of migraine-related functional disability, and provided greater satisfaction than placebo or subjects' usual acute treatment.Trial registrationClinicalTrials.gov identifier: NCT02856802
From modular invariants to graphs: the modular splitting method
We start with a given modular invariant M of a two dimensional su(n)_k
conformal field theory (CFT) and present a general method for solving the
Ocneanu modular splitting equation and then determine, in a step-by-step
explicit construction, 1) the generalized partition functions corresponding to
the introduction of boundary conditions and defect lines; 2) the quantum
symmetries of the higher ADE graph G associated to the initial modular
invariant M. Notice that one does not suppose here that the graph G is already
known, since it appears as a by-product of the calculations. We analyze several
su(3)_k exceptional cases at levels 5 and 9.Comment: 28 pages, 7 figures. Version 2: updated references. Typos corrected.
su(2) example has been removed to shorten the paper. Dual annular matrices
for the rejected exceptional su(3) diagram are determine
Orders and dimensions for sl(2) or sl(3) module categories and Boundary Conformal Field Theories on a torus
After giving a short description, in terms of action of categories, of some
of the structures associated with sl(2) and sl(3) boundary conformal field
theories on a torus, we provide tables of dimensions describing the semisimple
and co-semisimple blocks of the corresponding weak bialgebras (quantum
groupoids), tables of quantum dimensions and orders, and tables describing
induction - restriction. For reasons of size, the sl(3) tables of induction are
only given for theories with self-fusion (existence of a monoidal structure).Comment: 25 pages, 5 tables, 9 figures. Version 2: updated references. Typos
corrected. Several proofs added. Examples of ADE and generalized ADE
trigonometric identities have been removed to shorten the pape
From conformal embeddings to quantum symmetries: an exceptional SU(4) example
We briefly discuss several algebraic tools that are used to describe the
quantum symmetries of Boundary Conformal Field Theories on a torus. The
starting point is a fusion category, together with an action on another
category described by a quantum graph. For known examples, the corresponding
modular invariant partition function, which is sometimes associated with a
conformal embedding, provides enough information to recover the whole
structure. We illustrate these notions with the example of the conformal
embedding of SU(4) at level 4 into Spin(15) at level 1, leading to the
exceptional quantum graph E4(SU(4)).Comment: 22 pages, 3 color figures. Version 2: We changed the color of figures
(ps files) in such a way that they are still understood when converted to
gray levels. Version 3: Several references have been adde
Data-Oblivious Graph Algorithms in Outsourced External Memory
Motivated by privacy preservation for outsourced data, data-oblivious
external memory is a computational framework where a client performs
computations on data stored at a semi-trusted server in a way that does not
reveal her data to the server. This approach facilitates collaboration and
reliability over traditional frameworks, and it provides privacy protection,
even though the server has full access to the data and he can monitor how it is
accessed by the client. The challenge is that even if data is encrypted, the
server can learn information based on the client data access pattern; hence,
access patterns must also be obfuscated. We investigate privacy-preserving
algorithms for outsourced external memory that are based on the use of
data-oblivious algorithms, that is, algorithms where each possible sequence of
data accesses is independent of the data values. We give new efficient
data-oblivious algorithms in the outsourced external memory model for a number
of fundamental graph problems. Our results include new data-oblivious
external-memory methods for constructing minimum spanning trees, performing
various traversals on rooted trees, answering least common ancestor queries on
trees, computing biconnected components, and forming open ear decompositions.
None of our algorithms make use of constant-time random oracles.Comment: 20 page
Rouse Chains with Excluded Volume Interactions: Linear Viscoelasticity
Linear viscoelastic properties for a dilute polymer solution are predicted by
modeling the solution as a suspension of non-interacting bead-spring chains.
The present model, unlike the Rouse model, can describe the solution's
rheological behavior even when the solvent quality is good, since excluded
volume effects are explicitly taken into account through a narrow Gaussian
repulsive potential between pairs of beads in a bead-spring chain. The use of
the narrow Gaussian potential, which tends to the more commonly used
delta-function repulsive potential in the limit of a width parameter "d" going
to zero, enables the performance of Brownian dynamics simulations. The
simulations results, which describe the exact behavior of the model, indicate
that for chains of arbitrary but finite length, a delta-function potential
leads to equilibrium and zero shear rate properties which are identical to the
predictions of the Rouse model. On the other hand, a non-zero value of "d"
gives rise to a prediction of swelling at equilibrium, and an increase in zero
shear rate properties relative to their Rouse model values. The use of a
delta-function potential appears to be justified in the limit of infinite chain
length. The exact simulation results are compared with those obtained with an
approximate solution which is based on the assumption that the non-equilibrium
configurational distribution function is Gaussian. The Gaussian approximation
is shown to be exact to first order in the strength of excluded volume
interaction, and is found to be accurate above a threshold value of "d", for
given values of chain length and strength of excluded volume interaction.Comment: Revised version. Long chain limit analysis has been deleted. An
improved and corrected examination of the long chain limit will appear as a
separate posting. 32 pages, 9 postscript figures, LaTe
A Minimal Periods Algorithm with Applications
Kosaraju in ``Computation of squares in a string'' briefly described a
linear-time algorithm for computing the minimal squares starting at each
position in a word. Using the same construction of suffix trees, we generalize
his result and describe in detail how to compute in O(k|w|)-time the minimal
k-th power, with period of length larger than s, starting at each position in a
word w for arbitrary exponent and integer . We provide the
complete proof of correctness of the algorithm, which is somehow not completely
clear in Kosaraju's original paper. The algorithm can be used as a sub-routine
to detect certain types of pseudo-patterns in words, which is our original
intention to study the generalization.Comment: 14 page
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